Cleared Traditional

K772053 - LINE CHARGER MODEL LC-100

K772053 is the FDA 510(k) clearance for LINE CHARGER MODEL LC-100 by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K772053 · Datascope Corp. · Cardiovascular device

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Nov 1977

Decision

Days

Class 2

Risk

K772053 is an FDA 510(k) clearance for the LINE CHARGER MODEL LC-100. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977 after a review of 9 days - a notably fast clearance cycle.

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: 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 Datascope Corp. devices

Submission Details

510(k) Number	K772053 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 31, 1977
Decision Date	November 09, 1977
Days to Decision	9 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

116d faster than avg

Panel avg: 125d · This submission: 9d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 115

Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K772053.

ACUTE CARDIAC CARE SYSTEM

K772006 · Physio-Control Corp. · Nov 1977

PHYSIOLOGICAL MONITOR MODEL 871

K772056 · Datascope Corp. · Nov 1977

HEARTRATE METER MODEL 650, P/N 000119

K772097 · Quinton, Inc. · Nov 1977

ECG SCOPE MODEL 7833

K771360 · Hewlett-Packard Co. · Aug 1977

SURGIPULSE HEART RATE MONITOR

K771199 · Stryker Corp. · Jul 1977

MONITOR, NEONATAL, MODEL 78261A

K770022 · Hewlett-Packard Co. · Feb 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K772053

Datascope Corp.

Mchenry, IL · US

Regulatory profile

136 submissions 135 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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