Cleared Traditional

K862003 - CIRCUIT ANES. BREATHING & COMPONENTS

K862003 is the FDA 510(k) clearance for CIRCUIT ANES. BREATHING & COMPONENTS by Vital Signs, Inc.. It is a Class 1 Anesthesiology device (product code CAI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K862003 · Vital Signs, Inc. · Anesthesiology device
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Jul 1986
Decision
41d
Days
Class 1
Risk

K862003 is an FDA 510(k) clearance for the CIRCUIT ANES. BREATHING & COMPONENTS. Classified as Circuit, Breathing (w Connector, Adaptor, Y Piece) (product code CAI), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on July 7, 1986 after a review of 41 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 Vital Signs, Inc. devices

Submission Details

510(k) Number K862003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1986
Decision Date July 07, 1986
Days to Decision 41 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
99d faster than avg
Panel avg: 140d · This submission: 41d
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 43
Devices cleared under the same product code (CAI) and FDA review panel - the closest regulatory comparables to K862003.
AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
K873359 · American Pharmaseal Div. Ahsc · Nov 1987
BABYSET(TM) MODIFIED JACKSON-REES CIRCUIT W/VALVE
K871669 · Life Design Systems, Inc. · May 1987
PENLON CIRCLE SYSTEM
K864588 · Bear Medical Systems, Inc. · Feb 1987
CIRCUIT, ANES. BREATHING (NON-REBREATHING)
K861438 · Vital Signs, Inc. · May 1986
AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
K844149 · Ambu, Inc. · Nov 1984
BABYSET TM & PAC TM -PULMONARY ASSIST
K841264 · Life Design Systems, Inc. · Jun 1984