Cleared Traditional

K160667 - Anybattery C2 Rechargeable Battery

K160667 is an FDA 510(k) clearance for Anybattery C2 Rechargeable Battery, manufactured by Anybattery, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K160667 · Anybattery, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
428d
Days
Class 2
Risk

K160667 is an FDA 510(k) clearance for the Anybattery C2 Rechargeable Battery. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Anybattery, Inc. (Rosemont, US). The FDA issued a Cleared decision on May 11, 2017 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K160667

510(k) Number K160667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2016
Decision Date May 11, 2017
Days to Decision 428 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
303d slower than avg
Panel avg: 125d · This submission: 428d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 Consultant

Denterprise International, Inc. / 510k FDA Consulting
Claude Berthoin

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 475
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K160667.
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