Cleared Traditional

K811626 - MEDDARS/ULTRA IMAGER PULSE/PHON MODULE

K811626 is an FDA 510(k) clearance for MEDDARS/ULTRA IMAGER PULSE/PHON MODULE, manufactured by Honeywell, Inc.. The device is a Class 1 Cardiovascular device with product code DQC cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K811626 · Honeywell, Inc. · Cardiovascular device
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Jul 1981
Decision
22d
Days
Class 1
Risk

K811626 is an FDA 510(k) clearance for the MEDDARS/ULTRA IMAGER PULSE/PHON MODULE. Classified as Phonocardiograph (product code DQC), Class I - General Controls.

Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2390 - the FDA cardiovascular device oversight 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 Honeywell, Inc. devices

FDA 510(k) Submission Details - K811626

510(k) Number K811626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1981
Decision Date July 01, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

DQC Device Classification - Class 1, General Controls

Product Code DQC Phonocardiograph
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2390
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 - DQC Phonocardiograph

Devices cleared under the same product code (DQC) and FDA review panel - the closest regulatory comparables to K811626.
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · Acuson Corp. · Dec 1990
NIC-200 VENTRICULAR FUNCTION ANALYZER
K792466 · Nicolet Biomedical Instruments · Jan 1980
AMPLIFIER, PC-700
K780116 · Burdick Corp. · Feb 1978
PULSE/PHONOCARDIOGRAPHY CHANNEL, 144
K770757 · Honeywell, Inc. · May 1977
PHON/STRESS SYSTEM (#21126A)
K760464 · Hewlett-Packard Co. · Aug 1976