Cleared Traditional

K942438 - ALTAIR 6100 CASSETTE RECORDER

K942438 is an FDA 510(k) clearance for ALTAIR 6100 CASSETTE RECORDER, manufactured by Burdick, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K942438 · Burdick, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
77d
Days
Class 2
Risk

K942438 is an FDA 510(k) clearance for the ALTAIR 6100 CASSETTE RECORDER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Burdick, Inc. (Miltoon, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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.

FDA 510(k) Submission Details - K942438

510(k) Number K942438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date August 05, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 178
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K942438.
DIGITAL HOLTER RECORDER
K942781 · Agilent Technologies · Jan 1995
HEARTPRINT
K942862 · Medata, Inc. · Jan 1995
TRACKER 2/TRACKER 3 HOLTER RECORDER
K943278 · Reynolds Medical , Ltd. · Oct 1994
SCOLE 300 ECG RECORDER
K923664 · Scole Engineering Co. · Jan 1994
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K934660 · R & D Batteries, Inc. · Dec 1993
MULTITRAK-PLUS
K930894 · Zymed Medical Instrumentation · Nov 1993
K942438 · ALTAIR 6100 CASSETTE RECORDER
Download PDF FDA Summary Burdick, Inc.