Cleared Traditional

K894654 - FLEXHTR-1

K894654 is an FDA 510(k) clearance for FLEXHTR-1, manufactured by Bird Products Corp.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K894654 · Bird Products Corp. · Anesthesiology device
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Aug 1990
Decision
373d
Days
Class 2
Risk

K894654 is an FDA 510(k) clearance for the FLEXHTR-1. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Bird Products Corp. (Palm Spring, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - 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. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Bird Products Corp. devices

FDA 510(k) Submission Details - K894654

510(k) Number K894654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date August 01, 1990
Days to Decision 373 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 140d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZE Device Classification - Class 2, Special Controls

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
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 - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 25
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K894654.
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · Marquest Medical Products, Inc. · Jan 1997
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
BREATHING CIRCUIT W/HEATED WIRE
K880769 · Dryden Corp. · Aug 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · Intertech Resources, Inc. · Jul 1988
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
K881625 · Respiratory Care, Inc. · Jun 1988