Cleared Traditional

K853057 - TRIOS - M

K853057 is an FDA 510(k) clearance for TRIOS - M, manufactured by Biotronik Sales, Inc.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K853057 · Biotronik Sales, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1985
Decision
55d
Days
Class 3
Risk

K853057 is an FDA 510(k) clearance for the TRIOS - M. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Biotronik Sales, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 12, 1985 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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. High regulatory complexity profile. 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 Biotronik Sales, Inc. devices

FDA 510(k) Submission Details - K853057

510(k) Number K853057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date September 12, 1985
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 353
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K853057.
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K853590 · Cook Pacemaker Corp. · Oct 1985
COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
K853651 · Cook Pacemaker Corp. · Oct 1985
NEOS - M ABP
K853058 · Biotronik Sales, Inc. · Sep 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206 · Telectronics, Inc. · Sep 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435 · Cardiac Control Systems, Inc. · Aug 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017 · Ela Medical, Inc. · Jul 1985