Cleared Traditional

K854012 - AMERICAN PHARMASEAL HUMIDAIR CONDENSER

K854012 is an FDA 510(k) clearance for AMERICAN PHARMASEAL HUMIDAIR CONDENSER, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 Anesthesiology device with product code BYD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K854012 · American Pharmaseal Div. Ahsc · Anesthesiology device
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Dec 1985
Decision
64d
Days
Class 1
Risk

K854012 is an FDA 510(k) clearance for the AMERICAN PHARMASEAL HUMIDAIR CONDENSER. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on December 3, 1985 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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 American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K854012

510(k) Number K854012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date December 03, 1985
Days to Decision 64 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
76d faster than avg
Panel avg: 140d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

BYD Device Classification - Class 1, General Controls

Product Code BYD Condenser, Heat And Moisture (artificial Nose)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5375
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYD Condenser, Heat And Moisture (artificial Nose)

All 24
Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K854012.
INTERTECH(TM) HEAT AND MOISTURE EXCHANGER
K903519 · Intertech Resources, Inc. · Dec 1990
HUMIDI-FLEX TM
K885313 · Life Design Systems, Inc. · Oct 1989
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F
K864095 · Gambro, Inc. · Feb 1987
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
K844040 · Siemens Elema AB · Oct 1984
PALL HEAT MOISTURE EXCHANGING FILTER
K834292 · Pall Biomedical Products Co. · Apr 1984