Cleared Traditional

K881328 - MODEL 375 ECG

K881328 is an FDA 510(k) clearance for MODEL 375 ECG, manufactured by Birtcher Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K881328 · Birtcher Corp. · Cardiovascular device
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May 1988
Decision
50d
Days
Class 2
Risk

K881328 is an FDA 510(k) clearance for the MODEL 375 ECG. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Birtcher Corp. (El Monte, US). The FDA issued a Cleared decision on May 18, 1988 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Birtcher Corp. devices

FDA 510(k) Submission Details - K881328

510(k) Number K881328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1988
Decision Date May 18, 1988
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K881328.
OEC-7102 ECG/NIBP MONITOR
K882254 · Nihon Kohden America, Inc. · Nov 1988
MINIMON 7131B PATIENT MONITOR
K882197 · Kontron Instruments, Inc. · Aug 1988
MINIMON 7132B PATIENT MONITOR
K882198 · Kontron Instruments, Inc. · Jul 1988
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc. · Mar 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · Del Mar Avionics · Jan 1988