Cleared Traditional

K891997 - CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER

K891997 is an FDA 510(k) clearance for CATALOG #2270AAX, manufactured by Corometrics Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K891997 · Corometrics Medical Systems, Inc. · Obstetrics & Gynecology device
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Jun 1989
Decision
72d
Days
Class 2
Risk

K891997 is an FDA 510(k) clearance for the CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Corometrics Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on June 8, 1989 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2720 - 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 Corometrics Medical Systems, Inc. devices

FDA 510(k) Submission Details - K891997

510(k) Number K891997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date June 08, 1989
Days to Decision 72 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 160d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFM Device Classification - Class 2, Special Controls

Product Code HFM Monitor, Uterine Contraction, External (for Use In Clinic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2720
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 - HFM Monitor, Uterine Contraction, External (for Use In Clinic)

All 11
Devices cleared under the same product code (HFM) and FDA review panel - the closest regulatory comparables to K891997.
BUBBLE TOCO
K920152 · Utah Medical Products, Inc. · May 1993
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER
K910282 · Graphic Controls Corp. · Mar 1991
MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR
K894030 · Healthdyne, Inc. · Jan 1990
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K882080 · Aequitron Medical, Inc. · Mar 1989
EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET
K853856 · Aequitron Medical, Inc. · Mar 1986
TOCO DATA TELEPHONE TRANSMITTER DT100P
K840747 · Advantage Medical Systems, Inc. · Jun 1984