Cleared Traditional

K843011 - TERM GUARD 5000 UTERINE ACTIVITY

K843011 is an FDA 510(k) clearance for TERM GUARD 5000 UTERINE ACTIVITY, manufactured by Tokos Medical Corp.. The device is a Class 2 Obstetrics & Gynecology device with product code HFM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K843011 · Tokos Medical Corp. · Obstetrics & Gynecology device
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Nov 1984
Decision
93d
Days
Class 2
Risk

K843011 is an FDA 510(k) clearance for the TERM GUARD 5000 UTERINE ACTIVITY. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Tokos Medical Corp. (Washington, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 93 days - within the typical 510(k) review window.

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: 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 Tokos Medical Corp. devices

FDA 510(k) Submission Details - K843011

510(k) Number K843011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date November 01, 1984
Days to Decision 93 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
67d faster than avg
Panel avg: 160d · This submission: 93d
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 K843011.
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