Cleared Traditional

K811253 - CASSETTE READER

K811253 is an FDA 510(k) clearance for CASSETTE READER, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K811253 · American Edwards Laboratories · Cardiovascular device
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Jul 1981
Decision
66d
Days
Class 2
Risk

K811253 is an FDA 510(k) clearance for the CASSETTE READER. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 66 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.

View all American Edwards Laboratories devices

FDA 510(k) Submission Details - K811253

510(k) Number K811253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1981
Decision Date July 10, 1981
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 112
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K811253.
HOLTER RECORDER & PLAYBACK/ANALYSIS SYS
K822818 · Marquette Electronics, Inc. · Dec 1982
HOLTER KIT MODEL #5000 SERIES
K823414 · Andover Medical, Inc. · Dec 1982
CARDIOCASSETTE II #363
K821453 · Birtcher Corp. · May 1982
ADVANCEMED CCU DOCUMENTOR
K803222 · American Edwards Laboratories · Jan 1981
ADVANCEMED HOLTER RECORDERS
K803224 · American Edwards Laboratories · Jan 1981
MODEL 9200 VIS-U-SCAN
K801832 · Del Mar Avionics · Aug 1980