Written and maintained by CASRAI Editorial Board
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General product and regulatory information only; this page is not medical advice and does not describe how to perform any procedure.
Short answer
A surgical pack, also called a procedure pack or procedure tray, is a set of single-use items for one type of procedure, assembled into one package so the user does not gather each item separately. FDA does not treat “surgical pack” as one regulatory category: the agency’s term is convenience kit, and kits are classified by what they contain and the procedure they serve.
Definition and scope
FDA’s Convenience Kits Interim Regulatory Guidance (issued May 20, 1997; checked 2026-10-30) describes convenience kits as devices “comprised of legally marketed devices that are simply being assembled in kit form strictly for the ‘convenience’ of the purchaser or user.” A pack that bundles items such as drapes, gowns, gauze and instruments that are each already on the market fits this description.
The same guidance says the components should be legally marketed and bought already finished and packaged, whether as preamendments devices, 510(k)-exempt devices or 510(k)-cleared devices.
How a pack is handled in practice: what FDA’s guidance says
- Labeling. The guidance notes that kit labeling “tends to be rather basic,” identifying the assembler or manufacturer and the intended use, usually on the outer package. Assemblers must still comply with general controls, including registration, listing and the prohibition against misbranding.
- Sterilization. Kit assemblers “should carefully consider the impact of the sterilization process on individual kit components,” and should protect components that are sensitive to reprocessing, with surgical sutures given as an example.
- Enforcement discretion. FDA applies enforcement discretion when the kit is of a type on the guidance’s list (organized by medical specialty), uses components cleared through the 510(k) process, and the assembler can reasonably conclude that any further processing does not significantly affect safety or effectiveness.
- Records. “Documentation to support each of these determinations should be maintained in the assembler’s/manufacturer’s files.”
Types: how FDA codes some kits and trays
The table below lists FDA product codes whose names are kits or trays for surgical or procedural use, taken from the openFDA device classification database (index updated 2026-10-19; checked 2026-10-30). It shows that packs are classed by contents and procedure rather than under a single “surgical pack” heading.
| Product code | FDA device name | Class | Regulation |
|---|---|---|---|
| KDD | Kit, Surgical Instrument, Disposable | 1 | 21 CFR 878.4800 |
| PYH | Surgical Retractor Kit | 1 | 21 CFR 878.4800 |
| OGS | Myringotomy Procedure Kit | 2 | 21 CFR 874.3880 |
| OEZ | Cardiovascular Procedure Kit | 2 | 21 CFR 870.1200 |
| PPR | Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | 2 | 21 CFR 888.1100 |
| PPI | Hemodialysis Tray (Not A Start/Stop Kit) | 2 | 21 CFR 876.5820 |
| FJZ | Declotting Tray, Kit (Including Contents) | 2 | 21 CFR 876.5820 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 2 | 21 CFR 876.5130 |
For OGS, OEZ, PPI, PYH and PPR, FDA’s own definition says the code was established under the 1997 convenience kits guidance and that this type of kit is under enforcement discretion and does not require a premarket notification (510(k)) if it meets all criteria in the guidance. The database definitions for KDD, FJZ and FCM do not state this, so it should not be assumed for them.
Where it matters for labs, clinics and supply decisions
Because a pack is an assembly of separate devices, each component keeps its own regulatory status. For example, under 21 CFR 878.4370 (checked 2026-10-30) surgical drapes are class II devices with special controls, and certain listed types, including ENT drapes, disposable urological drapes, Kelly pads and ophthalmic drapes, are exempt from 510(k) subject to the limitations in 21 CFR 878.9. A pack that contains a drape is therefore only as well documented as that component and the assembler’s records.
Practical questions that follow from the guidance: who is named as the assembler on the outer label, whether the kit type appears on FDA’s list, and how the assembler documented its sterilization and further-processing conclusions.
Related CASRAI pages cover the single items often found in a pack: sterile drapes, the wound closure kit, the central line kit, the IV start kit and sterilization containers. For the sourcing angle, see pre-assembled procedure kits versus build-your-own.
Common misunderstandings
- “A surgical pack is one FDA device type.” The table above shows kits spread across several product codes, classes and regulations.
- “Every kit is exempt from 510(k).” Enforcement discretion applies only when the guidance’s conditions are met, and registration, listing and misbranding rules still apply.
- “Contents are standardized.” The guidance covers kit types by specialty; it does not set a standard contents list, so contents differ by assembler and procedure.
FAQ
What is a surgical pack?
A set of single-use items assembled in one package for a type of procedure. In FDA’s terms it is a convenience kit made from legally marketed devices.
Is a surgical pack the same as a procedure tray?
The terms are used for the same idea. FDA’s database uses both “kit” and “tray” in device names, for example Hemodialysis Tray (PPI) and Cardiovascular Procedure Kit (OEZ).
Does a surgical pack need FDA clearance?
Not always. FDA’s guidance describes enforcement discretion from premarket notification for listed kit types made from cleared components when the assembler reasonably concludes further processing does not significantly affect safety or effectiveness. The components themselves must be legally marketed.
Sources
- FDA, Convenience Kits Interim Regulatory Guidance, May 20, 1997; checked 2026-10-30.
- FDA, openFDA device classification API; checked 2026-10-30.
- 21 CFR 878.4370, Cornell Legal Information Institute; checked 2026-10-30.
