Cleared Traditional

K932006 - 1500 SERIES REGULATOR

K932006 is an FDA 510(k) clearance for 1500 SERIES REGULATOR, manufactured by Precision Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K932006 · Precision Medical, Inc. · Anesthesiology device
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Oct 1993
Decision
187d
Days
Class 1
Risk

K932006 is an FDA 510(k) clearance for the 1500 SERIES REGULATOR. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on October 25, 1993 after a review of 187 days - an extended review cycle.

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 Precision Medical, Inc. devices

FDA 510(k) Submission Details - K932006

510(k) Number K932006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1993
Decision Date October 25, 1993
Days to Decision 187 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 140d · This submission: 187d
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 12
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K932006.
VANGUARD SERIES GAS REGULATORS
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K896128 · Puritan Bennett Corp. · Jan 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K896152 · Puritan Bennett Corp. · Jan 1990
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · Instrumentation Industries, Inc. · Jun 1989