Cleared Traditional

K844421 - FOREGGER DOME VALVES

K844421 is an FDA 510(k) clearance for FOREGGER DOME VALVES, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K844421 · Puritan Bennett Corp. · Anesthesiology device
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Jan 1985
Decision
60d
Days
Class 2
Risk

K844421 is an FDA 510(k) clearance for the FOREGGER DOME VALVES. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K844421

510(k) Number K844421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1984
Decision Date January 14, 1985
Days to Decision 60 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
80d faster than avg
Panel avg: 140d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSZ Gas-machine, Anesthesia

All 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K844421.
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · Ohmeda Medical · Oct 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · Ohio Medical Products · Apr 1984
BAG-TO-VENTILATOR SELECTOR VALVE
K841274 · Ohio Medical Products · Apr 1984