Cleared Traditional

K881303 - TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER

K881303 is an FDA 510(k) clearance for TRITON MODEL 100 PULSED DOPPLER BLOOD F..., manufactured by Triton Technology, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K881303

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.

DPT Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (DPT) and FDA review panel - the closest regulatory comparables to K881303.
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APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
K873214 · General Electric Co. · Jun 1988
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K874138 · Datascope Corp. · Jun 1988
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K874861 · Acuson Computed Sonography · May 1988