Labor And Delivery Kit
The Labor and Delivery Kit is a pre-assembled collection of sterile supplies and instruments used by healthcare providers during the management of childbirth, established in accordance with FDA guidance from May 20, 1997, to standardize the components and regulatory classification of these kits. Classified as a Class 2 device under 21 CFR 884.4530 within the Obstetrics and Gynecology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLS
- Device Class
- FDA class 2
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K961993 | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) | Jul 03, 1996 | Substantially Equivalent | Devon Industries, Inc. |
| K960243 | CPR C-SECTION DELIVERY PACK | May 23, 1996 | Substantially Equivalent | Custom Pack Reliability |
| K940518 | C-SECTION TRAY | Aug 18, 1994 | Unknown | Cush Medical Products |
| K932216 | C-SECTION, LABOR & DELIVERY TRAYS (PACKS) | Apr 19, 1994 | Unknown | Associated Medical Products Co. |
| K936120 | LABOR AND DELIVERY TRAY | Mar 30, 1994 | Unknown | Cush Medical Products |
| K931722 | CARAPACE LABOR AND DELIVERY SETS | Mar 23, 1994 | Unknown | Carapace, Inc. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.