Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
An electric nasal aspirator is a battery or mains-powered suction device used to remove nasal secretions. This guide is for clinic staff, buyers and students who need to know what the device class is, how FDA classifies it, what a cleared model is tested for, and how it differs from a manual bulb syringe. Who uses it: parents and caregivers at home, and the clinic staff who advise them.
What is an electric nasal aspirator?
An electric nasal aspirator is a portable powered suction device whose motor pump creates negative pressure to draw nasal secretions and mucus out through a tip. In FDA’s records, cleared electric nasal aspirators are filed under product code BTA (“Pump, Portable, Aspiration (Manual Or Powered)”), regulation 21 CFR 878.4780 (powered suction pump), Class II.
The cleared indication for one 510(k) model (K241202, FDA letter dated 1 July 2024) reads: “intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.”
How does it work and what is it made of?
In the K241202 summary, the device “consists of main unit, and the suction portion working together as one unit.” A motor pump provides negative pressure, runs on a rechargeable battery charged through an external power adapter (not included with that device), and the user sets vacuum pressure with a button and an LED display. The part that touches the nose is a silicone tip (funnel nozzle).
Types: electric, manual bulb and other aspirators
| Type | How suction is produced | Source |
|---|---|---|
| Electric nasal aspirator | Motor pump creating negative pressure; rechargeable battery in the cleared model K241202 | FDA 510(k) K241202 |
| Manual bulb syringe | A rubber or silicone bulb with a narrow tip draws secretions out by manual suction | CASRAI guide: bulb syringe use in newborn and pediatric care |
| Manual or powered aspirator (regulatory grouping) | FDA’s product code BTA covers both “Manual Or Powered” portable aspiration pumps | FDA 510(k) K241202, classification name |
Nasal aspirator vs bulb syringe
The difference documented in the FDA record is the suction source: a bulb syringe is squeezed by hand, while an electric aspirator uses a motor pump with adjustable vacuum. Both fall in the same FDA product-code family (“Manual Or Powered”). The K241202 submission contains no clinical comparison of the two, so this page makes no claim that one clears better than the other. For bulb syringes, see CASRAI’s bulb syringe guide and ear bulb syringe guide; shop-side, bulb syringes.
Nose Frida vs bulb syringe
“Nose Frida” is a brand name, not an FDA device category, and it does not appear in the K241202 record. The category-level fact above (product code BTA covering manual and powered aspirators) is what FDA’s record supports; check a specific product’s own instructions for use for its design and intended age.
What FDA clearance says (and does not say)
- Regulation 21 CFR 878.4780 defines a powered suction pump as “a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient’s airway or respiratory support system,” and classifies it as Class II.
- The K241202 device was cleared through the 510(k) route as substantially equivalent to predicate K222547, another electric nasal aspirator.
- That submission states: “No clinical test data was used to support the decision of substantial equivalence.” Its non-clinical testing covered product service life, software validation, electromagnetic compatibility and electrical safety, usability, function, and biocompatibility.
- The cleared population is children aged 2-12 in a home environment. Neither the regulation text nor the clearance letter contains a “hospital-grade” category, so that wording on packaging is a marketing term to check against the product’s own labeling, not an FDA class. Any use for infants outside the cleared indication should be checked against that product’s instructions for use.
Specifications for one cleared model
The table lists values the K241202 submission gives for its subject device (models HTD2601US and H2609AU). They describe that one model, not every electric nasal aspirator.
| Parameter | Stated value | Source |
|---|---|---|
| Vacuum pressure | 68 kPa | K241202 |
| Flow | 1.6 L/min (listed as maximum flow value) | K241202 |
| Noise level | 60 dB | K241202 |
| Power consumption | 1.5 W | K241202 |
| Motor and battery | 3.7 V DC; rechargeable Li-ion battery | K241202 |
| Water resistance | IP22 | K241202 |
| Tip material | Silicone; mucosal contact stated as under 24 hours | K241202 |
| Electrical and battery standards listed | ANSI AAMI ES60601-1, ANSI AAMI HA60601-1-11, IEC 60601-1-6, IEC 62133-2; EMC: ANSI AAMI IEC 60601-1-2 | K241202 |
| Biocompatibility standards listed | ISO 10993-1, -5, -10, -23 | K241202 |
What to check on a product label
The facts that define a cleared device are on its clearance and labeling: the cleared age range (2-12 years in K241202), the cleared setting (home), and the standards and testing the manufacturer lists. Compare marketing claims against the product’s instructions for use.
Safe use and handling basics
The cleared indication is intermittent removal of nasal secretions, not continuous suction. Follow the manufacturer’s instructions for use for cleaning, charging and tip replacement; this page gives no cleaning protocol or frequency limit. For manual suction devices see CASRAI’s bulb syringe guide; for related respiratory equipment see respiratory therapy equipment.
Common mistakes
- Treating “hospital-grade” as a regulatory class (see above).
- Assuming a device cleared for children 2-12 at home is cleared for newborns or clinical settings.
- Reading the regulation text as describing battery models: 21 CFR 878.4780 says AC-powered or compressed air-powered, yet battery-powered aspirators such as K241202 are cleared under it.
- Treating one model’s vacuum and flow figures as a standard for the whole category.
FAQ
What is a nasal aspirator?
A nasal aspirator is a device that uses suction to remove nasal secretions; FDA groups manual and powered versions under product code BTA.
What is an electric nasal aspirator?
A nasal aspirator in which a motor pump generates the suction, and Class II under 21 CFR 878.4780.
What is a manual nasal aspirator?
One in which the user generates suction by hand, as with a squeezed bulb syringe. See the bulb syringe guide linked above.
Is an electric nasal aspirator FDA-approved?
Models are cleared (not approved) through the 510(k) process; K241202, for example, was cleared on 1 July 2024 for children aged 2-12 at home.
Sources
- FDA 510(k) K241202, electric nasal aspirator (HTD2601US, H2609AU), clearance letter 1 July 2024: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241202.pdf (checked 30 October 2026).
- 21 CFR 878.4780, Powered suction pump (Cornell LII text): https://www.law.cornell.edu/cfr/text/21/878.4780 (checked 30 October 2026).
