Cleared Traditional

K915564 - SPIROS

K915564 is an FDA 510(k) clearance for SPIROS, manufactured by Life Support Products, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K915564 · Life Support Products, Inc. · Anesthesiology device
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Jan 1992
Decision
49d
Days
Class 2
Risk

K915564 is an FDA 510(k) clearance for the SPIROS. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Life Support Products, Inc. devices

FDA 510(k) Submission Details - K915564

510(k) Number K915564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1991
Decision Date January 30, 1992
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 140d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K915564.
LSPI AUTOMATIC VENTILATOR, MODEL AV3000
K932199 · Life Support Products, Inc. · Nov 1993
LSPI AUTOMATIC VENTILATOR
K932200 · Life Support Products, Inc. · Nov 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · J. H. Emerson Co. · Jan 1993
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · Ambu, Inc. · May 1991
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · Impact Instrumentation, Inc. · Dec 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990