Cleared Traditional

K151135 - MODEL 621/624 BIOMAGNETOMETER

K151135 is an FDA 510(k) clearance for MODEL 621/624 BIOMAGNETOMETER, manufactured by Tristan Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K151135 · Tristan Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
321d
Days
Class 2
Risk

K151135 is an FDA 510(k) clearance for the MODEL 621/624 BIOMAGNETOMETER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Tristan Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on March 15, 2016 after a review of 321 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: Standard predicate-based submission. Elevated predicate reliance 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.

FDA 510(k) Submission Details - K151135

510(k) Number K151135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2015
Decision Date March 15, 2016
Days to Decision 321 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
196d slower than avg
Panel avg: 125d · This submission: 321d
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

Eugene Hirschkoff, Consultant
EUGENE HIRSCHKOFF

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 K151135.
PC ECG
K161302 · Edan Instruments, Inc. · Jul 2016
Portable ECG Monitor
K152863 · Contec Medical Systems Co.,Ltd · Jun 2016
Diagnostic Station DS20
K152043 · Schiller AG · May 2016
ANI Monitor
K142969 · Mdoloris Medical Systems Sas · Feb 2016
Digital Electrocardiograph
K160092 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · Feb 2016
PC ECG
K152427 · Edan Instruments, Inc. · Feb 2016