FDA product code MCY: Wound Dressing Kit
MCY is the FDA product code for wound dressing kit. It is a Class II device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel. FDA has cleared 24 510(k) submissions under MCY, from 21 different applicants. The average 510(k) review took 126 days (median 90). FDA has posted 101 recalls for MCY devices, 23 initiated in the last five years.
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Wound Dressing Kit |
| Device class | Class II |
| Regulation | 21 CFR 880.5075 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MCY clearance
Top MCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Convatec, A Division of E.R. Squibb & Sons | 2 | 1995-06-12 |
| Catalina Biomedical Corp. | 2 | 1991-10-18 |
| Medical Device Inspection Co., Inc. | 2 | 1991-10-18 |
| Johnson & Johnson Medical, Inc. | 1 | 1997-03-21 |
| Grand Medical Products | 1 | 1996-11-27 |
16 more applicants have MCY clearances. See the full list in Caduvo.
Most recent MCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970721 | Johnson & Johnson Medical, Inc. | DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEM | 1997-03-21 | 22 |
| K963719 | Grand Medical Products | CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY | 1996-11-27 | 72 |
| K960585 | Suncoast Medical Products, Inc. | WOUND CARE COMPRESSION SYSTEM (WCCS) | 1996-04-26 | 74 |
| K952334 | Busse Hospital Disposables, Inc. | DRESSING CHANGE TRAY | 1995-07-14 | 57 |
| K951022 | Convatec, A Division of E.R. Squibb & Sons | CIRCULON SYSTEM STEP 1 | 1995-06-12 | 97 |
Recalls for MCY devices
101 product recalls in 32 recall events; 23 initiated in the last five years and 22 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2022 | 3 |
| 2023 | 6 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 8 |
Frequently asked questions
What is FDA product code MCY?
MCY is the FDA product code for wound dressing kit. It is a Class II device, regulated under 21 CFR 880.5075 and reviewed by the General and Plastic Surgery panel.
What device class is MCY?
Class II, regulation 21 CFR 880.5075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MCY?
Across 24 cleared submissions the average was 126 days from receipt to decision (median 90).
Which companies have the most MCY clearances?
Convatec, A Division of E.R. Squibb & Sons (2); Catalina Biomedical Corp. (2); Medical Device Inspection Co., Inc. (2); Johnson & Johnson Medical, Inc. (1); Grand Medical Products (1).
Have MCY devices been recalled?
Yes: 101 product recalls across 32 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MCY
- Run a recall and safety report across every MCY manufacturer
- Watch product code MCY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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