Cleared Traditional

K843223 - FLOW CONTROLLER

K843223 is an FDA 510(k) clearance for FLOW CONTROLLER, manufactured by Precision Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K843223 · Precision Medical, Inc. · Anesthesiology device
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Sep 1984
Decision
42d
Days
Class 2
Risk

K843223 is an FDA 510(k) clearance for the FLOW CONTROLLER. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 Precision Medical, Inc. devices

FDA 510(k) Submission Details - K843223

510(k) Number K843223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1984
Decision Date September 27, 1984
Days to Decision 42 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
98d faster than avg
Panel avg: 140d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K843223.
PULMANEX
K854037 · Life Design Systems, Inc. · Nov 1985
RESUSCITATOR, PULMONARY, MANUAL
K844729 · Life Design Systems, Inc. · Mar 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · Vital Signs, Inc. · Feb 1985
RESPIRONICS VENTEASY
K842693 · Respironics, Inc. · Aug 1984
SAMSON'S NEWBORN LUNG INFLATOR 340-1000
K842487 · J. H. Emerson Co. · Jul 1984
MARK III RESUSCITATOR
K840349 · Ambu, Inc. · Feb 1984