Cleared Traditional

K882080 - MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882080 · Aequitron Medical, Inc. · Obstetrics & Gynecology device
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Mar 1989
Decision
288d
Days
Class 2
Risk

K882080 is an FDA 510(k) clearance for the MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.. Classified as Monitor, Uterine Contraction, External (for Use In Clinic) (product code HFM), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 1, 1989 after a review of 288 days - an extended review 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: 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.

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Submission Details

510(k) Number K882080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1988
Decision Date March 01, 1989
Days to Decision 288 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
128d slower than avg
Panel avg: 160d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.