Cleared Traditional

K850449 - DIGITAL PULSE METER HRM-100E & ETC.

K850449 is an FDA 510(k) clearance for DIGITAL PULSE METER HRM-100E & ETC., manufactured by Sanyo Electric, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 667-day FDA review.

K850449 · Sanyo Electric, Inc. · Cardiovascular device
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Dec 1986
Decision
667d
Days
Class 2
Risk

K850449 is an FDA 510(k) clearance for the DIGITAL PULSE METER HRM-100E & ETC.. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Sanyo Electric, Inc. (Hyogo, Japan, JP). The FDA issued a Cleared decision on December 4, 1986 after a review of 667 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sanyo Electric, Inc. devices

FDA 510(k) Submission Details - K850449

510(k) Number K850449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1985
Decision Date December 04, 1986
Days to Decision 667 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
542d slower than avg
Panel avg: 125d · This submission: 667d
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 K850449.
COMPANION 50 REGULATOR/FLOWMETER
K872443 · Puritan Bennett Corp. · Jul 1987
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494 · Advantage Medical Systems, Inc. · Dec 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463 · Nihon Kohden America, Inc. · Dec 1986
LIFE-WATCH MONITOR LT-8
K863534 · Computerized Medical Systems, Inc. · Nov 1986
ERG 550 ERGOMETER BICYCLE
K854491 · Robert Bosch Corp. · Jun 1986
ERG 551 ERGOMETER, BICYCLE
K854492 · Robert Bosch Corp. · Jun 1986