Cleared Traditional

K781697 - PRESSURE, LOW/HIGH MODEL C1070

K781697 is an FDA 510(k) clearance for PRESSURE, manufactured by Timeter Instrument Corp.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K781697 · Timeter Instrument Corp. · Anesthesiology device
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Oct 1978
Decision
17d
Days
Class 2
Risk

K781697 is an FDA 510(k) clearance for the PRESSURE, LOW/HIGH MODEL C1070. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Timeter Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1978 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - the FDA anesthesiology and respiratory 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 Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K781697

510(k) Number K781697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1978
Decision Date October 27, 1978
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAP Device Classification - Class 2, Special Controls

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 41
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K781697.
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · Draeger Medical, Inc. · Sep 1980
BUNN MODEL #40 LOW PRESSURE ALARM
K790370 · The John Bunn Co. · Mar 1979
PNEUMOGARD MODEL 1230
K781714 · Novametrix Medical Systems, Inc. · Nov 1978
MODEL 65 HIGH & LOW PRESSURE ALARM
K780863 · The John Bunn Co. · Aug 1978