Cleared Traditional

K881303 - TRITON MODEL 100 PULSED DOPPLER BLOOD F...

K881303 is the FDA 510(k) clearance for TRITON MODEL 100 PULSED DOPPLER BLOOD F... by Triton Technology, Inc.. It is a Class 2 Cardiovascular device (product code DPT) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K881303 · Triton Technology, Inc. · Cardiovascular device
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Nov 1988
Decision
246d
Days
Class 2
Risk

K881303 is an FDA 510(k) clearance for the TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER. Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Triton Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - 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. Standard predicate reliance. 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 Triton Technology, Inc. devices

Submission Details

510(k) Number K881303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date November 29, 1988
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
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 - DPT Probe, Blood-flow, Extravascular

All 13
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K881303.
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K905728 · Hewlett-Packard Co. · Mar 1991
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · Kontron Instruments, Inc. · Dec 1990
HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM
K896435 · Hewlett-Packard Co. · Feb 1990
APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · Jun 1988
ACCUCOM 2
K874138 · Datascope Corp. · Jun 1988
SSH-160A ULTRASONIC PULSED ECHO IMAGING SYSTEM
K875266 · Toshiba Medical Systems · Apr 1988