Cleared Traditional

K851334 - AIRLIFE ELECTRONIC INCENTIVE SPIROMETER

K851334 is an FDA 510(k) clearance for AIRLIFE ELECTRONIC INCENTIVE SPIROMETER, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K851334 · American Pharmaseal Div. Ahsc · Anesthesiology device
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Aug 1985
Decision
127d
Days
Class 2
Risk

K851334 is an FDA 510(k) clearance for the AIRLIFE ELECTRONIC INCENTIVE SPIROMETER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Glendale, US). The FDA issued a Cleared decision on August 6, 1985 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K851334

510(k) Number K851334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date August 06, 1985
Days to Decision 127 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
13d faster than avg
Panel avg: 140d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 36
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K851334.
VITAL PEP
K984468 · Vital Signs, Inc. · Jun 1999
TVS II ELECTRONIC INCENTIVE SPIROMETER
K910138 · Monaghan Medical Corp. · Mar 1991
AMBU RMT VALVE
K873579 · Ambu, Inc. · Dec 1987
ELECATH INFANT ARTERIAL & VENOUS CANNU
K842369 · Electro-Catheter Corp. · Aug 1984
VOFLEX
K840239 · Dhd Medical Products Div. Diemolding Corp. · Mar 1984
VOLUREX II
K833337 · Dhd Medical Products Div. Diemolding Corp. · Nov 1983