510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960243Substantially Equivalent

CPR C-Section Delivery Pack

Custom Pack Reliability, Orlando FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960243 is the FDA 510(k) clearance record for CPR C-SECTION DELIVERY PACK, a class II device, cleared for Custom Pack Reliability on under FDA product code MLS (Labor And Delivery Kit). FDA's definition for product code MLS reads: "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...". FDA records list 21 510(k) clearances for Custom Pack Reliability, from to . As of , FDA records show no recalls naming K960243.

Clearance record

Decision date
Received
(128 days to decision)
Product code
MLS Labor And Delivery Kit
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Custom Pack Reliability 4207 Vineland Rd., M-1, Orlando FL
510(k) summary
Statement
Third party review
No

Clearances, product code MLS

Trailing 12 months

FDA records hold no clearances under product code MLS in the trailing twelve months.

FDA records show no clearances under product code MLS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260