Cleared Special

SERUM PROTEIN SUBSTITUTE (K003734) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003734 · Sage Biopharma · Obstetrics & Gynecology device
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Dec 2000
Decision
17d
Days
Class 2
Risk

K003734 is an FDA 510(k) clearance for the SERUM PROTEIN SUBSTITUTE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Sage Biopharma (Irvine, US). The FDA issued a Cleared decision on December 21, 2000 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6180 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sage Biopharma devices

Submission Details

510(k) Number K003734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date December 21, 2000
Days to Decision 17 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d faster than avg
Panel avg: 160d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQL Media, Reproductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6180
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 - MQL Media, Reproductive

All 258
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