Cleared Traditional

K011606 - PURESPERM BUFFER

K011606 is an FDA 510(k) clearance for PURESPERM BUFFER, manufactured by Nidacon International AB. 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.

K011606 · Nidacon International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
49d
Days
Class 2
Risk

K011606 is an FDA 510(k) clearance for the PURESPERM BUFFER. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Nidacon International AB (Deer Field, US). The FDA issued a Cleared decision on July 12, 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 - K011606

510(k) Number K011606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date July 12, 2001
Days to Decision 49 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
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 K011606.
SPERMCATCH
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K011346 · Nidacon International AB · Jun 2001