Cleared Traditional

CITADEL CPAP ACCESSORY KIT (K771017) - FDA 510(k) Clearance

Class I Anesthesiology device.

K771017 · Sherwood Medical Industries · Anesthesiology device
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Jun 1977
Decision
8d
Days
Class 1
Risk

K771017 is an FDA 510(k) clearance for the CITADEL CPAP ACCESSORY KIT. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5240 - 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 Sherwood Medical Industries devices

Submission Details

510(k) Number K771017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1977
Decision Date June 14, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 139d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5240
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 - CAI Circuit, Breathing (w Connector, Adaptor, Y Piece)

All 183
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K771017.
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K893919 · Baxter Healthcare Corp · Sep 1989
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · Baxter Healthcare Corp · Apr 1988
SPIROMETER ISOLATION VALVE #8890
K833088 · Boehringer Mannheim Corp. · Oct 1983