Cleared Traditional

K002846 - HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR

K002846 is an FDA 510(k) clearance for HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR, manufactured by Headstar Medical Products Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K002846 · Headstar Medical Products Co., Ltd. · Anesthesiology device
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Jun 2001
Decision
267d
Days
Class 2
Risk

K002846 is an FDA 510(k) clearance for the HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Headstar Medical Products Co., Ltd. (Taipei Hsien, CN). The FDA issued a Cleared decision on June 6, 2001 after a review of 267 days - an extended review 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: 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.

FDA 510(k) Submission Details - K002846

510(k) Number K002846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2000
Decision Date June 06, 2001
Days to Decision 267 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
127d slower than avg
Panel avg: 140d · This submission: 267d
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 150
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K002846.
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
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V*CARE MANUAL RESUSCITATOR
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AMBU NEONATE SILICONE RESUSCITATOR
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RUSCH MANUAL RESUSCITATOR BAG
K993194 · Rusch, Inc. · Mar 2000
1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE
K991861 · Sims Portex, Inc. · Jan 2000