Cleared Traditional

NON-LINTING DELIVERY BLANKET (K932035) - FDA 510(k) Clearance

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

K932035 · Amsco Sterile Recoveries, Inc. · Obstetrics & Gynecology device
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May 1994
Decision
394d
Days
Class 2
Risk

K932035 is an FDA 510(k) clearance for the NON-LINTING DELIVERY BLANKET. Classified as Table, Obstetric (and Accessories) (product code KNC), Class II - Special Controls.

Submitted by Amsco Sterile Recoveries, Inc. (Clearwater, US). The FDA issued a Cleared decision on May 26, 1994 after a review of 394 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4900 - 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 Amsco Sterile Recoveries, Inc. devices

Submission Details

510(k) Number K932035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1993
Decision Date May 26, 1994
Days to Decision 394 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
234d slower than avg
Panel avg: 160d · This submission: 394d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNC Table, Obstetric (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4900
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.