Cleared Traditional

K980814 - PURESPERM

K980814 is an FDA 510(k) clearance for PURESPERM, 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 112-day FDA review.

K980814 · Nidacon International AB · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
112d
Days
Class 2
Risk

K980814 is an FDA 510(k) clearance for the PURESPERM. 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 June 23, 1998 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nidacon International AB devices

FDA 510(k) Submission Details - K980814

510(k) Number K980814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date June 23, 1998
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 160d · This submission: 112d
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 168
Devices cleared under the same product code (MQL) and FDA review panel - the closest regulatory comparables to K980814.
HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI
K983586 · Irvine Scientific Sales Co., Inc. · Feb 1999
P-1 (PREIMPLANTATION STAGE ONE) MEDIUM
K983589 · Irvine Scientific Sales Co., Inc. · Feb 1999
HUMAN SERUM ALBUMIN (HSA)
K983584 · Irvine Scientific Sales Co., Inc. · Feb 1999
ISOLATE
K971809 · Irvine Scientific Sales Co., Inc. · Jul 1997
SPERM SELECT(TM)
K864524 · Pharmacia, Inc. · Feb 1987