Cleared Special

K003734 - SERUM PROTEIN SUBSTITUTE

K003734 is an FDA 510(k) clearance for SERUM PROTEIN SUBSTITUTE, manufactured by Sage Biopharma. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Special 510(k) pathway after a 17-day FDA review.

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

FDA 510(k) Submission Details - K003734

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.

MQL Device Classification - Class 2, Special Controls

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 184
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K003734.
SYNVITRO FLUSH
K003163 · Medicult A/S · Mar 2001
SUPRASPERM SYSTEM
K003404 · Medicult A/S · Mar 2001
COMPLETE HUMAN TUBAL FLUID (HTF) WITH SERUM SUBSTITUTE SUPPLEMENT, MODEL 9922
K003278 · Irvine Scientific Sales Co., Inc. · Jan 2001
DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301
K003448 · Irvine Scientific Sales Co., Inc. · Dec 2000
COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
K002385 · Cook Ob/Gyn · Sep 2000
COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
K002383 · Cook Ob/Gyn · Sep 2000