FDA product code KDC: Instrument, Surgical, Disposable
KDC is the FDA product code for instrument, surgical, disposable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 67 510(k) submissions under KDC, from 46 different applicants. The average 510(k) review took 74 days (median 57). FDA has posted 38 recalls for KDC devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Surgical, Disposable |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KDC clearance
Top KDC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euro-Med Intl. | 7 | 1986-05-02 |
| Instranetics, Inc. | 5 | 1981-07-20 |
| Omega-Med Intl., Inc. | 4 | 1984-03-05 |
| Medcare Products | 4 | 1983-09-12 |
| Devon Industries, Inc. | 3 | 1983-03-08 |
41 more applicants have KDC clearances. See the full list in Caduvo.
Most recent KDC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K943229 | Y.M.K. International Co., Ltd. | DISPOSABLE SURGICAL SCISSORS AND FORCEPS | 1994-08-19 | 44 |
| K936226 | Meadox Medicals, Div. Boston Scientific Corp. | SURGIMED BREAST LOCALIZATION NEEDLE WIRE SET | 1994-03-07 | 68 |
| K920153 | Techstyles | THERMUFF BAG | 1992-07-01 | 170 |
| K920263 | Phoenix Instruments Div. | MANUAL SURGICAL INSTRUMENTS | 1992-05-06 | 106 |
| K915064 | American Medical Mfg., Inc. | DISPOSABLE CAUTERY ABRASIVE PAD | 1992-03-11 | 124 |
Recalls for KDC devices
38 product recalls in 12 recall events; 3 initiated in the last five years and 2 still open. Most recent: 2025-04-09.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KDC?
KDC is the FDA product code for instrument, surgical, disposable. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is KDC?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDC?
Across 67 cleared submissions the average was 74 days from receipt to decision (median 57).
Which companies have the most KDC clearances?
Euro-Med Intl. (7); Instranetics, Inc. (5); Omega-Med Intl., Inc. (4); Medcare Products (4); Devon Industries, Inc. (3).
Have KDC devices been recalled?
Yes: 38 product recalls across 12 recall events; the most recent began 2025-04-09.
Next steps
- Run an FDA pathway report with predicate devices for product code KDC
- Run a recall and safety report across every KDC manufacturer
- Watch product code KDC 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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