Labor Delivery Tray
FDA 510(k) K912054 · Medical Device Inspection Co., Inc.
510(k) numberK912054
Submission
- Device name
- Labor Delivery Tray
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- May 9, 1991
- Decision date
- January 21, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HFW – Clamp, Umbilical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K041332 | Joey Clamp Opening ToolHFW · Traditional | Maternus, Inc. | 06/25/2004SE |
| K033846 | Kaen Yih Umbilical Cord ClampHFW · Traditional | Kaen Yih Enterprise Co., Ltd. | 03/11/2004SE |
| K020718 | Securline Umbilical Cord Clamp #3505 Sterile #3515 Non-SterileHFW · Traditional | Precision Dynamics Corp. | 06/03/2002SE |
| K021055 | Busse Umbilical Cord Clamp CutterHFW · Traditional | Busse Hospital Disposables, Inc. | 04/29/2002SE |
| K012917 | Dynarex Umbilical Cord Lamp, Models 6833 and 6833-BHFW · Traditional | Dynarex Corp. | 11/28/2001SE |
| K011621 | Koala Clamp, Koala Clamp and CutterHFW · Traditional | Maternus, Inc. | 08/10/2001SE |
| K010695 | Koala ClampHFW · Traditional | Maternus, Inc. | 05/03/2001SE |
| K010835 | Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp…HFW · Traditional | Busse Hospital Disposables, Inc. | 04/30/2001SE |
| K000227 | UmbicutHFW · Traditional | Pollak (Intl.), Ltd. | 04/27/2000SE |
| K994367 | Umbilical Cord ClampHFW · Traditional | Medical Sales Co. | 03/17/2000SE |
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| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K912075 | C-Section TrayKNA · Traditional | 04/07/1992SESK |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
Questions and answers
When was Labor Delivery Tray cleared by the FDA?
Labor Delivery Tray (K912054) received a 510(k) decision of Unknown on January 21, 1992, 257 days after the submission was received.
What is the product code of K912054?
The FDA product code is HFW – Clamp, Umbilical, a Class II (moderate risk) device regulated under 21 CFR 884.4530.