Cleared Traditional

K931722 - CARAPACE LABOR AND DELIVERY SETS (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931722 · Carapace, Inc. · Obstetrics & Gynecology device
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Mar 1994
Decision
350d
Days
Class 2
Risk

K931722 is an FDA 510(k) clearance for the CARAPACE LABOR AND DELIVERY SETS. Classified as Labor And Delivery Kit (product code MLS), Class II - Special Controls.

Submitted by Carapace, Inc. (Broken Arrow, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Carapace, Inc. devices

Submission Details

510(k) Number K931722 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 07, 1993
Decision Date March 23, 1994
Days to Decision 350 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 160d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.