Cleared Traditional

K003448 - DEXTRAN SERUM SUPPLEMENT (DSS)

K003448 is an FDA 510(k) clearance for DEXTRAN SERUM SUPPLEMENT (DSS), manufactured by Irvine Scientific Sales Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K003448 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology device
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Dec 2000
Decision
31d
Days
Class 2
Risk

K003448 is an FDA 510(k) clearance for the DEXTRAN SERUM SUPPLEMENT (DSS), MODEL 9301. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on December 7, 2000 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Irvine Scientific Sales Co., Inc. devices

FDA 510(k) Submission Details - K003448

510(k) Number K003448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date December 07, 2000
Days to Decision 31 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 160d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 167
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K003448.
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
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
MEDI-CULT UNIVERSAL IVF-MEDIUM
K991279 · Medicult A/S · Jul 2000