Cleared Traditional

K894361 - LIFECARE PRESSURE ALARM CAT. NO. 34-010

K894361 is an FDA 510(k) clearance for LIFECARE PRESSURE ALARM CAT. NO. 34-010, manufactured by Lifecare Services, Inc.. The device is a Class 2 Anesthesiology device with product code CAP cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K894361 · Lifecare Services, Inc. · Anesthesiology device
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Oct 1989
Decision
83d
Days
Class 2
Risk

K894361 is an FDA 510(k) clearance for the LIFECARE PRESSURE ALARM CAT. NO. 34-010. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Lifecare Services, Inc. (Lafayette, US). The FDA issued a Cleared decision on October 5, 1989 after a review of 83 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 Lifecare Services, Inc. devices

FDA 510(k) Submission Details - K894361

510(k) Number K894361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date October 05, 1989
Days to Decision 83 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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 K894361.
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K902276 · Respironics, Inc. · Aug 1990
INFANT C.P.A.P. MONITOR
K896136 · Hudson Oxygen Therapy Sales Co. · Jan 1990
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K895747 · Hudson Oxygen Therapy Sales Co. · Oct 1989
OHMEDA 5500 AIRWAY PRESSURE MONITOR
K864536 · Ohmeda Medical · Jan 1987
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · Draeger Medical, Inc. · May 1986
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
K861330 · Sechrist Industries, Inc. · Apr 1986