Cleared Traditional

K851245 - ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851245 · Applinc · Anesthesiology device
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May 1985
Decision
49d
Days
Class 2
Risk

K851245 is an FDA 510(k) clearance for the ADDITION OF 50% OXYGEN TO APPLINC SAVING BREATH HY. 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 Applinc (San Diego, US). The FDA issued a Cleared decision on May 15, 1985 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. 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 Applinc devices

Submission Details

510(k) Number K851245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1985
Decision Date May 15, 1985
Days to Decision 49 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 139d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 44
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K851245.
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