DeviceClearance

Product code MLS— Obstetrics/Gynecology

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)

Classification name
Labor And Delivery Kit
Device class
Class 2
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
6
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code MLS under 21 CFR 884.4530, via openFDA

Market context for product code MLS

FDA has cleared 6 devices under product code MLS between 1994 and 1996, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MLS

Recent clearances under product code MLS

Data sourced from openFDA. This site is unofficial and independent of the FDA.