Cleared Traditional

K982225 - SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504

K982225 is an FDA 510(k) clearance for SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESU..., manufactured by Spiracle Technology. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K982225 · Spiracle Technology · Anesthesiology device
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Oct 1998
Decision
126d
Days
Class 2
Risk

K982225 is an FDA 510(k) clearance for the SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Spiracle Technology (Fountain Valley, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 126 days - within the typical 510(k) review window.

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: 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 Spiracle Technology devices

FDA 510(k) Submission Details - K982225

510(k) Number K982225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date October 28, 1998
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 50
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K982225.
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K020899 · Pneupac , Ltd. · Dec 2002
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · Vortran Medical Technology 1, Inc. · Jul 2000
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
RESPIRTECHPRO
K973975 · Vortran Medical Technology 1, Inc. · Jun 1998
PARAPAC
K960515 · Pneupac , Ltd. · Oct 1996
DRAGER MEDICAL AIR COMPRESSOR
K951126 · Drager, Inc. · Mar 1995