Cleared Traditional

K853058 - NEOS - M ABP

K853058 is an FDA 510(k) clearance for NEOS - M ABP, 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 56-day FDA review.

K853058 · Biotronik Sales, Inc. · Cardiovascular device
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Sep 1985
Decision
56d
Days
Class 3
Risk

K853058 is an FDA 510(k) clearance for the NEOS - M ABP. 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 13, 1985 after a review of 56 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 - K853058

510(k) Number K853058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1985
Decision Date September 13, 1985
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 K853058.
BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
K854143 · Telectronics, Inc. · Nov 1985
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
TRIOS - M
K853057 · 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