Medical Disposable Bedding
FDA 510(k) K924420 · Hill-Rom, Inc.
510(k) numberK924420
Submission
- Device name
- Medical Disposable Bedding
- Applicant
- Hill-Rom, Inc.
Batesville, TN, US - Received
- September 1, 1992
- Decision date
- December 10, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNC – Table, Obstetric (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4900
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KNC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001261 | L720 Examination ChairKNC · Traditional | Luneau Gynecologie SA | 06/08/2000SE |
| K932035 | Non-Linting Delivery BlanketKNC · Traditional | Amsco Sterile Recoveries, Inc. | 05/26/1994SE |
| K914544 | BD6000 the Optima & BD5000 Birthing BedKNC · Traditional | Lic Care, Inc. | 11/24/1993SE |
| K915779 | Affinity Bed Model 3600 SeriesKNC · Traditional | Hill-Rom, Inc. | 02/24/1993SE |
| K903973 | Gardosi Birthing CushionKNC · Traditional | Graphic Controls Corp. | 09/27/1990SE |
| K884868 | Obstetrical Safety SystemKNC · Traditional | Buckman Co., Inc. | 03/01/1989SE |
| K870745 | Stryker Model 977 Birthing BedKNC · Traditional | Stryker Corp. | 02/27/1987SE |
| K864194 | Palmer Obstetric BraceKNC · Traditional | Ad-Tech Medical Instrument Corp | 01/14/1987SE |
| K862931 | Merivaara Obstetric Chair/Bed-Model 358KNC · Traditional | Global Medical Prods, Inc. | 08/07/1986SE |
| K861030 | Labor-Delivery Stretch/BedKNC · Traditional | Adel Medical , Ltd. | 04/23/1986SE |
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| K260211 | Dashboard (P007000)MSX · Traditional | 08/13/2026SE |
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| K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #)…BZQ · Traditional | 05/07/2018SE |
| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | 03/10/2015SE |
| K122473 | Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2IOQ · Traditional | 06/03/2013SE |
| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
| K973705 | Contor Table SurfaceDWJ · Traditional | 08/07/1998SE |
| K981081 | BrightstarFSY · Traditional | 04/29/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
Questions and answers
When was Medical Disposable Bedding cleared by the FDA?
Medical Disposable Bedding (K924420) received a 510(k) decision of Substantially Equivalent on December 10, 1993, 465 days after the submission was received.
What is the product code of K924420?
The FDA product code is KNC – Table, Obstetric (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4900.