Cleared Traditional

K970902 - MEDILOG FD4

K970902 is an FDA 510(k) clearance for MEDILOG FD4, manufactured by Oxford Instruments Medical Systems. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K970902 · Oxford Instruments Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
55d
Days
Class 2
Risk

K970902 is an FDA 510(k) clearance for the MEDILOG FD4. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Oxford Instruments Medical Systems (Clearwater, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 55 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 Oxford Instruments Medical Systems devices

FDA 510(k) Submission Details - K970902

510(k) Number K970902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1997
Decision Date May 05, 1997
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 93
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K970902.
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
K971670 · Galix Biomedical Instrumentation, Inc. · Jan 1998
DM-400 HOLTER ECG CASSETTE RECORDER
K970298 · Diagnostic Monitoring · Aug 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP5-FP
K971604 · Alexander Mfg. Co. · Jul 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · Del Mar Avionics · Mar 1997
VITALOGRAPH 2110 SOFTWARE INTERFACE
K950854 · Vitalograph , Ltd. · Oct 1995
HOLTER PACERCORDER(R)
K950020 · Del Mar Avionics · Aug 1995