Cleared Traditional

K853194 - ERA-20

K853194 is an FDA 510(k) clearance for ERA-20, manufactured by Biotronik Sales, Inc.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 589-day FDA review.

K853194 · Biotronik Sales, Inc. · Cardiovascular device
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Mar 1987
Decision
589d
Days
Class 2
Risk

K853194 is an FDA 510(k) clearance for the ERA-20. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on March 11, 1987 after a review of 589 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K853194

510(k) Number K853194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date March 11, 1987
Days to Decision 589 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
464d slower than avg
Panel avg: 125d · This submission: 589d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 28
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K853194.
EXTERNAL DEMAND PACEMAKER
K923621 · Oscor Medical Corp. · May 1993
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768 · Oscor, Inc. · Dec 1983
STERILE PACKAGING
K811092 · Telectronics, Inc. · Jul 1981
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981