Cleared Traditional

K880161 - ACKRAD PEDIATRIC C.P.A.P. SYSTEM

K880161 is an FDA 510(k) clearance for ACKRAD PEDIATRIC C.P.A.P. SYSTEM, manufactured by Ackrad Laboratories. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K880161 · Ackrad Laboratories · Anesthesiology device
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Mar 1988
Decision
51d
Days
Class 2
Risk

K880161 is an FDA 510(k) clearance for the ACKRAD PEDIATRIC C.P.A.P. SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on March 4, 1988 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K880161

510(k) Number K880161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date March 04, 1988
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 37
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K880161.
MODIFIED SANDERS BI-PAPEASY
K883825 · Respironics, Inc. · Dec 1988
NASAL CPAP SYSTEM
K881833 · Healthdyne, Inc. · Jun 1988
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · Ohmeda Medical · Apr 1988
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · Puritan Bennett Corp. · Sep 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758 · Life Design Systems, Inc. · Jul 1986