Cleared Traditional

K991334 - MEDI-CULT HYALURONIDASE

K991334 is an FDA 510(k) clearance for MEDI-CULT HYALURONIDASE, manufactured by Medicult A/S. The device is a Class 2 Obstetrics & Gynecology device with product code MQL cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K991334 · Medicult A/S · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
428d
Days
Class 2
Risk

K991334 is an FDA 510(k) clearance for the MEDI-CULT HYALURONIDASE. Classified as Media, Reproductive (product code MQL), Class II - Special Controls.

Submitted by Medicult A/S (San Diego, US). The FDA issued a Cleared decision on June 20, 2000 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Medicult A/S devices

FDA 510(k) Submission Details - K991334

510(k) Number K991334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date June 20, 2000
Days to Decision 428 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
268d slower than avg
Panel avg: 160d · This submission: 428d
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 K991334.
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
MEDI-CULT M3 MEDIUM
K991331 · Medicult A/S · Jun 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · Vitrolife Sweden AB · May 2000
MEDI-CULT BLASTOCYST FREEZING & THAWING PACKS, INTERNAL CATALOG NUMBERS (1012, 1015)
K991471 · Medicult A/S · May 2000
MEDI-CULT EMBRYO FREEZING MEDIUM INTERNAL CATAGLOG NUMBERS 1079
K991472 · Medicult A/S · May 2000