Cleared Traditional

K991216 - HOFFMAN IVF-1

K991216 is an FDA 510(k) clearance for HOFFMAN IVF-1, manufactured by (Arms) Hoffman Surgical Equipment, Ivf Division. The device is a Class 2 Obstetrics & Gynecology device with product code MQG cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K991216 · (Arms) Hoffman Surgical Equipment, Ivf Division · Obstetrics & Gynecology device
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Aug 1999
Decision
118d
Days
Class 2
Risk

K991216 is an FDA 510(k) clearance for the HOFFMAN IVF-1. Classified as Accessory, Assisted Reproduction (product code MQG), Class II - Special Controls.

Submitted by (Arms) Hoffman Surgical Equipment, Ivf Division (Conshohocken, US). The FDA issued a Cleared decision on August 5, 1999 after a review of 118 days - within the typical 510(k) review window.

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: 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 (Arms) Hoffman Surgical Equipment, Ivf Division devices

FDA 510(k) Submission Details - K991216

510(k) Number K991216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1999
Decision Date August 05, 1999
Days to Decision 118 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
42d faster than avg
Panel avg: 160d · This submission: 118d
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 22
Devices cleared under the same product code (MQG) and FDA review panel - the closest regulatory comparables to K991216.
GENX CODA AIR PURIFICATION SYSTEM
K001486 · Intl., Inc. · Sep 2000
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
K000394 · Rocket Medical Plc · Feb 2000
COOK ULTRA QUIET VACUUM PUMP & REGULATOR
K992070 · Cook Urological, Inc. · Oct 1999
FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
K991408 · Thermoquest Corp. · Jul 1999
THERMOPLATE
K991263 · Tokai Hit Co., Ltd. · Jul 1999
K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24, L-24E, L-25, L-25E, L-26, L-26E,L
K991229 · Henning Knudsen Engineering A/S · Jun 1999