Cleared Traditional

K030864 - VADI MANUAL RESUSCITATOR

K030864 is an FDA 510(k) clearance for VADI MANUAL RESUSCITATOR, manufactured by Vedi Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K030864 · Vedi Corp. · Anesthesiology device
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Jan 2004
Decision
318d
Days
Class 2
Risk

K030864 is an FDA 510(k) clearance for the VADI MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Vedi Corp. (Plano, US). The FDA issued a Cleared decision on January 30, 2004 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K030864

510(k) Number K030864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2003
Decision Date January 30, 2004
Days to Decision 318 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
178d slower than avg
Panel avg: 140d · This submission: 318d
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 207
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K030864.
STURDY MANUAL RESUSCITATOR
K032596 · Sturdy Industrial Co., Ltd. · Aug 2004
MERLIN RESUSCITATOR
K031395 · Merlin Medical Limited · Jul 2004
BAWMED E-Z BAG RESUSCITATOR
K031434 · Bawmed UK · Feb 2004
SMART BAG MO
K021328 · O-Two Systems International, Inc. · Jun 2003
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793 · Portex, Inc. · Feb 2003
NELLCOR INDGO MANUAL RESUSCITATOR
K023494 · Nellcor Puritan Bennett, Inc. · Feb 2003
K030864 · VADI MANUAL RESUSCITATOR
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