Cleared Traditional

K070210 - GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM

K070210 is an FDA 510(k) clearance for GIRAFFE AND PANDA T- PIECE RESUSCITATIO..., manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K070210 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
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Apr 2007
Decision
88d
Days
Class 2
Risk

K070210 is an FDA 510(k) clearance for the GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Ohmeda Medical (Laurel, US). The FDA issued a Cleared decision on April 20, 2007 after a review of 88 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K070210

510(k) Number K070210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date April 20, 2007
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
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 67
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K070210.
PORTABLE VENTILATOR, MODEL EPV-100
K072214 · Allied Healthcare Products, Inc. · Mar 2008
AUTOVENT 4000 WITH CPAP
K070636 · Allied Healthcare Products, Inc. · Jul 2007
AUTOVENT MODEL 4000
K070120 · Allied Healthcare Products, Inc. · May 2007
UNI-VENT MODEL 73X
K051476 · Impact Instrumentation, Inc. · Oct 2005
CAREVENT ATV+ AND CAREVENT MRI
K051469 · O-Two Medical Technologies, Inc. · Sep 2005
PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS
K051322 · Smiths Medical International , Ltd. · Aug 2005