Cleared Traditional

K912174 - SALTER LABS DISPOSABLE NIPPLE AND NUT

K912174 is an FDA 510(k) clearance for SALTER LABS DISPOSABLE NIPPLE AND NUT, manufactured by Salter Labs. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K912174 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
69d
Days
Class 1
Risk

K912174 is an FDA 510(k) clearance for the SALTER LABS DISPOSABLE NIPPLE AND NUT. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on July 24, 1991 after a review of 69 days - a notably fast clearance 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: 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 Salter Labs devices

FDA 510(k) Submission Details - K912174

510(k) Number K912174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date July 24, 1991
Days to Decision 69 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
71d faster than avg
Panel avg: 140d · This submission: 69d
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 K912174.
VANGUARD SERIES GAS REGULATORS
K942751 · Buckman Co., Inc. · Feb 1995
1500 SERIES REGULATOR
K932006 · Precision Medical, Inc. · Oct 1993
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · Precision Medical, Inc. · Aug 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
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