Cleared Traditional

K780445 - LIQUID CRYSTAL DISPLAY DIGITAL WATCH

K780445 is an FDA 510(k) clearance for LIQUID CRYSTAL DISPLAY DIGITAL WATCH, manufactured by Hughes Aircraft Co.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K780445 · Hughes Aircraft Co. · Cardiovascular device
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Jun 1978
Decision
91d
Days
Class 2
Risk

K780445 is an FDA 510(k) clearance for the LIQUID CRYSTAL DISPLAY DIGITAL WATCH. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hughes Aircraft Co. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1978 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hughes Aircraft Co. devices

FDA 510(k) Submission Details - K780445

510(k) Number K780445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1978
Decision Date June 19, 1978
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K780445.
AS7 & AS8 MONITORS
K790552 · Narco Air-Shields · May 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979
CARDIAC MINISCOPE & MINIGRAPH
K780297 · Arco Medical Products Co. · May 1978
CSS-60 DIGITAL HEART RATE METER
K780702 · Burdick Corp. · May 1978
ECG MONITORING SYSTEM,
K780404 · Quinton, Inc. · Mar 1978