FDA product code KDD: Kit, Surgical Instrument, Disposable
KDD is the FDA product code for kit, surgical instrument, 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 62 510(k) submissions under KDD, from 51 different applicants. The average 510(k) review took 87 days (median 59). FDA has posted 251 recalls for KDD devices, 210 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Kit, Surgical Instrument, 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 KDD clearance
Top KDD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulti-Med Intl., Inc. | 3 | 1993-06-17 |
| Pro-Pak | 3 | 1982-07-09 |
| American Medical Disposable, Inc. | 3 | 1980-12-30 |
| Megadyne Medical Products, Inc. | 2 | 1991-03-28 |
| E.M. Adams | 2 | 1984-09-07 |
46 more applicants have KDD clearances. See the full list in Caduvo.
Most recent KDD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072814 | Covidien | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | 2008-04-16 | 198 |
| K011514 | Kencap , Ltd. | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | 2001-08-13 | 88 |
| K971317 | National Healthcare Mfg. Corp. | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | 1997-05-08 | 29 |
| K960456 | Denver Biomaterials, Inc. | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | 1996-04-01 | 62 |
| K936255 | Associated Medical | CUSTOM CV PACK | 1994-03-31 | 91 |
Recalls for KDD devices
251 product recalls in 60 recall events; 210 initiated in the last five years and 212 still open. Most recent: 2026-07-29.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 7 |
| 2022 | 5 |
| 2023 | 12 |
| 2024 | 175 |
| 2025 | 6 |
| 2026 | 12 |
Frequently asked questions
What is FDA product code KDD?
KDD is the FDA product code for kit, surgical instrument, 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 KDD?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KDD?
Across 62 cleared submissions the average was 87 days from receipt to decision (median 59).
Which companies have the most KDD clearances?
Ulti-Med Intl., Inc. (3); Pro-Pak (3); American Medical Disposable, Inc. (3); Megadyne Medical Products, Inc. (2); E.M. Adams (2).
Have KDD devices been recalled?
Yes: 251 product recalls across 60 recall events; the most recent began 2026-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code KDD
- Run a recall and safety report across every KDD manufacturer
- Watch product code KDD 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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