Cleared Traditional

K991271 - OOCYTE ASPIRATION NEEDLE

K991271 is an FDA 510(k) clearance for OOCYTE ASPIRATION NEEDLE, manufactured by Casmed UK. The device is a Class 2 Obstetrics & Gynecology device with product code MQE cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K991271 · Casmed UK · Obstetrics & Gynecology device
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Mar 2000
Decision
330d
Days
Class 2
Risk

K991271 is an FDA 510(k) clearance for the OOCYTE ASPIRATION NEEDLE. Classified as Needle, Assisted Reproduction (product code MQE), Class II - Special Controls.

Submitted by Casmed UK (Surrey, GB). The FDA issued a Cleared decision on March 8, 2000 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6100 - 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. Elevated predicate reliance profile. 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 Casmed UK devices

FDA 510(k) Submission Details - K991271

510(k) Number K991271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date March 08, 2000
Days to Decision 330 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
170d slower than avg
Panel avg: 160d · This submission: 330d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQE Device Classification - Class 2, Special Controls

Product Code MQE Needle, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6100
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 - MQE Needle, Assisted Reproduction

All 23
Devices cleared under the same product code (MQE) and FDA review panel - the closest regulatory comparables to K991271.
EMBRYON ULTRASOUND NEEDLE GUIDE
K032015 · Rocket Medical Plc · Aug 2003
COOPERSURGICAL OOCYTE RECOVERY NEEDLES
K023930 · CooperSurgical, Inc. · Jan 2003
EMBRYON SINGLE AND DOUBLE LUMEN NEEDLES
K000205 · Rocket Medical Plc · Apr 2000
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K994417 · Cook Urological, Inc. · Mar 2000
OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138
K992308 · Lifetek Medical, Inc. · Sep 1999
DOUBLE LUMEN NEEDLE
K991020 · Intl., Inc. · Sep 1999