Cleared Traditional

K000394 - CRAFT DUO-VAC SUCTION UNIT AND CRAFT SU...

K000394 is an FDA 510(k) clearance for CRAFT DUO-VAC SUCTION UNIT AND CRAFT SU..., manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K000394 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
22d
Days
Class 2
Risk

K000394 is an FDA 510(k) clearance for the CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by Rocket Medical Plc (Washington, Tyne & Wear, GB). The FDA issued a Cleared decision on February 29, 2000 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6120 - 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 - K000394

510(k) Number K000394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2000
Decision Date February 29, 2000
Days to Decision 22 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
138d faster than avg
Panel avg: 160d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQG Device Classification - Class 2, Special Controls

Product Code MQG Accessory, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6120
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 - MQG Accessory, Assisted Reproduction

All 13
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K000394.
PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
K014160 · Cook Urological, Inc. · Feb 2002
CODA INCUBATOR CELLMATE
K001600 · Intl., Inc. · Nov 2000
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999
COOK MINI-INCUBATOR
K983642 · Cook Ob/Gyn · Feb 1999
COOK TEST TUBE HEATER
K983609 · Cook Ob/Gyn · Dec 1998