Cleared Traditional

K915505 - REGULATOR FLOWMETER

K915505 is an FDA 510(k) clearance for REGULATOR FLOWMETER, manufactured by Lifeguard Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K915505 · Lifeguard Medical Products, Inc. · Anesthesiology device
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Apr 1992
Decision
135d
Days
Class 1
Risk

K915505 is an FDA 510(k) clearance for the REGULATOR FLOWMETER. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Lifeguard Medical Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 135 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.

FDA 510(k) Submission Details - K915505

510(k) Number K915505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date April 22, 1992
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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 54
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K915505.
1500 SERIES REGULATOR
K932006 · Precision Medical, Inc. · Oct 1993
AMBU OXYGEN REGULATOR
K921125 · Amg, LLC · Sep 1992
GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
K915154 · C.G.H. Medical, Inc. · May 1992
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
K914271 · C.G.H. Medical, Inc. · Apr 1992
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · Salter Labs · Jul 1991
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · Precision Medical, Inc. · Aug 1990
K915505 · REGULATOR FLOWMETER
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