Cleared Traditional

K011481 - 10% PVP

Also marketed or referenced as:
10% PVP IN EBSS SOLUTION

K011481 is an FDA 510(k) clearance for 10% PVP, manufactured by Conception Technologies. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K011481 · Conception Technologies · Obstetrics & Gynecology device
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Jul 2001
Decision
49d
Days
Class 2
Risk

K011481 is an FDA 510(k) clearance for the 10% PVP. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Conception Technologies (Irvine, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 49 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.

FDA 510(k) Submission Details - K011481

510(k) Number K011481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2001
Decision Date July 02, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 161d · This submission: 49d
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 259
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K011481.
NIDOIL
K012123 · Nidacon International AB · Aug 2001
OIL FOR EMBRYO CULTURE
K011938 · Irvine Scientific Sales Co., Inc. · Jul 2001
PURESPERM BUFFER
K011606 · Nidacon International AB · Jul 2001
HYALURONIDASE IN HTF MEDIUM
K011573 · Conception Technologies · Jul 2001
READYSWIM
K011346 · Nidacon International AB · Jun 2001
OIL FOR TISSUE CULTURE
K011462 · Conception Technologies · Jun 2001
K011481 · 10% PVP
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