Cleared Traditional

K960243 - CPR C-SECTION DELIVERY PACK

K960243 is an FDA 510(k) clearance for CPR C-SECTION DELIVERY PACK, manufactured by Custom Pack Reliability. The device is a Class 2 Obstetrics & Gynecology device with product code MLS cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K960243 · Custom Pack Reliability · Obstetrics & Gynecology device
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May 1996
Decision
128d
Days
Class 2
Risk

K960243 is an FDA 510(k) clearance for the CPR C-SECTION DELIVERY PACK. Classified as Labor And Delivery Kit (product code MLS), Class II - Special Controls.

Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on May 23, 1996 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Custom Pack Reliability devices

FDA 510(k) Submission Details - K960243

510(k) Number K960243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date May 23, 1996
Days to Decision 128 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 160d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLS Device Classification - Class 2, Special Controls

Product Code MLS Labor And Delivery Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MLS Labor And Delivery Kit

Devices cleared under the same product code (MLS) and FDA review panel - the closest regulatory comparables to K960243.
BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)
K961993 · Devon Industries, Inc. · Jul 1996
C-SECTION TRAY
K940518 · Cush Medical Products · Aug 1994
C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
K932216 · Associated Medical Products Co. · Apr 1994
LABOR AND DELIVERY TRAY
K936120 · Cush Medical Products · Mar 1994
CARAPACE LABOR AND DELIVERY SETS
K931722 · Carapace, Inc. · Mar 1994