Cleared Traditional

K000656 - EMBRYON GIFT TRANSFER CATHETERS/SETS

K000656 is an FDA 510(k) clearance for EMBRYON GIFT TRANSFER CATHETERS/SETS, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K000656 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
10d
Days
Class 2
Risk

K000656 is an FDA 510(k) clearance for the EMBRYON GIFT TRANSFER CATHETERS/SETS. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on March 9, 2000 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - 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.

View all Rocket Medical Plc devices

FDA 510(k) Submission Details - K000656

510(k) Number K000656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date March 09, 2000
Days to Decision 10 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
150d faster than avg
Panel avg: 160d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQF Device Classification - Class 2, Special Controls

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
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 - MQF Catheter, Assisted Reproduction

All 42
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K000656.
IUI CATHETER, MODEL 9057
K052059 · Inntec, Inc. · Nov 2005
EMBRYO TRANSFER CATHETER WITH ACCESSORY STYLET, MODELS 9018, 9023, 9018-S, 9023-S
K050521 · Inntec, Inc. · May 2005
MORTON IUI CATHETERS
K041470 · Fertility Technology Resources, Inc. · Nov 2004
EMBRYON TRANSFER CATHETERS/SETS
K994327 · Rocket Medical Plc · Feb 2000
EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER
K992307 · Fertility Technology Resources, Inc. · Sep 1999
EMBRYO TRANSFER CATHETER CC GLIDER
K991266 · Intl., Inc. · Sep 1999