Cleared Traditional

K873286 - DISPOSABLE

K873286 is an FDA 510(k) clearance for DISPOSABLE, manufactured by Hospitak, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K873286 · Hospitak, Inc. · Anesthesiology device
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Oct 1987
Decision
70d
Days
Class 2
Risk

K873286 is an FDA 510(k) clearance for the DISPOSABLE, MANUAL PULMONARY RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Hospitak, Inc. devices

FDA 510(k) Submission Details - K873286

510(k) Number K873286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1987
Decision Date October 26, 1987
Days to Decision 70 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
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K873286.
PULMONARY RESUSCITATOR, MODIFICATION
K892221 · Life Design Systems, Inc. · May 1989
PULMANEX TM (NEO-NATAL SIZE)
K884068 · Life Design Systems, Inc. · Nov 1988
AMBU SPUR (SINGLE PATIENT USE RESUSCITATOR)
K883434 · Ambu, Inc. · Sep 1988
PULMANEX TM (MODIFICATION)
K863026 · Life Design Systems, Inc. · Aug 1986
PULMANEX (TM)
K860693 · Life Design Systems, Inc. · Mar 1986
PULMANEX
K854037 · Life Design Systems, Inc. · Nov 1985