Cleared Traditional

K852333 - DOWNS VPAP CIRCUIT

K852333 is an FDA 510(k) clearance for DOWNS VPAP CIRCUIT, manufactured by Vital Signs, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K852333 · Vital Signs, Inc. · Anesthesiology device
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Oct 1985
Decision
138d
Days
Class 1
Risk

K852333 is an FDA 510(k) clearance for the DOWNS VPAP CIRCUIT. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Signs, Inc. devices

FDA 510(k) Submission Details - K852333

510(k) Number K852333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date October 16, 1985
Days to Decision 138 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
2d faster than avg
Panel avg: 140d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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 - CAN Regulator, Pressure, Gas Cylinder

All 19
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K852333.
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PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
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BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · Instrumentation Industries, Inc. · Jun 1989
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985
PORTABLE OXYGEN SYSTEM
K830844 · Puritan Bennett Corp. · May 1983
MS-303-OXYGEN REGULATOR SHIELD
K810679 · Instrumentation Industries, Inc. · Apr 1981