FDA product code KNC: Table, Obstetric (And Accessories)
KNC is the FDA product code for table, obstetric (and accessories). It is a Class II device, regulated under 21 CFR 884.4900 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 26 510(k) submissions under KNC, from 23 different applicants. The average 510(k) review took 124 days (median 56). FDA has posted 12 recalls for KNC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Table, Obstetric (And Accessories) |
| Device class | Class II |
| Regulation | 21 CFR 884.4900 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KNC clearance
Top KNC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Adel Medical , Ltd. | 3 | 1986-04-23 |
| Hill-Rom, Inc. | 2 | 1993-12-10 |
| Luneau Gynecologie SA | 1 | 2000-06-08 |
| Amsco Sterile Recoveries, Inc. | 1 | 1994-05-26 |
| Lic Care, Inc. | 1 | 1993-11-24 |
18 more applicants have KNC clearances. See the full list in Caduvo.
Most recent KNC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K001261 | Luneau Gynecologie SA | L720 EXAMINATION CHAIR | 2000-06-08 | 50 |
| K932035 | Amsco Sterile Recoveries, Inc. | NON-LINTING DELIVERY BLANKET | 1994-05-26 | 394 |
| K924420 | Hill-Rom, Inc. | MEDICAL DISPOSABLE BEDDING | 1993-12-10 | 465 |
| K914544 | Lic Care, Inc. | BD6000 THE OPTIMA & BD5000 BIRTHING BED | 1993-11-24 | 776 |
| K915779 | Hill-Rom, Inc. | AFFINITY BED MODEL 3600 SERIES | 1993-02-24 | 428 |
Recalls for KNC devices
12 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-05-06.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code KNC?
KNC is the FDA product code for table, obstetric (and accessories). It is a Class II device, regulated under 21 CFR 884.4900 and reviewed by the Obstetrics and Gynecology panel.
What device class is KNC?
Class II, regulation 21 CFR 884.4900. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KNC?
Across 26 cleared submissions the average was 124 days from receipt to decision (median 56).
Which companies have the most KNC clearances?
Adel Medical , Ltd. (3); Hill-Rom, Inc. (2); Luneau Gynecologie SA (1); Amsco Sterile Recoveries, Inc. (1); Lic Care, Inc. (1).
Have KNC devices been recalled?
Yes: 12 product recalls across 8 recall events; the most recent began 2025-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code KNC
- Run a recall and safety report across every KNC manufacturer
- Watch product code KNC 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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