Cleared Traditional

K800151 - EMIT TOBRAMYCIN CONTROL

K800151 is an FDA 510(k) clearance for EMIT TOBRAMYCIN CONTROL, manufactured by Syva Co.. The device is a Class 2 Toxicology device with product code DPW cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K800151 · Syva Co. · Toxicology device
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Feb 1980
Decision
14d
Days
Class 2
Risk

K800151 is an FDA 510(k) clearance for the EMIT TOBRAMYCIN CONTROL. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 870.2100 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K800151

510(k) Number K800151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1980
Decision Date February 05, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 Toxicology devices follow this clearance model.

Regulatory Peers - DPW Flowmeter, Blood, Cardiovascular

All 138
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K800151.
DOPPLER ULTRASOUND BLOOD FLOWMETER
K811246 · Irex Corp. · Aug 1981
DOPSCAN MODEL 1050
K810561 · Carolina Medical Electronics · Apr 1981
ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE
K801802 · Medical Testing System, Inc. · Jan 1981
VASCULIZER
K791418 · Diagnostics Intl. · Oct 1979
BLOOD FLOWMETER SYSTEM
K780302 · Medtronic Vascular · Apr 1978
ARTERIAL DIAGNOSTIC UNIT (ADU)
K770115 · Medical Electronic Devices, Inc. · Feb 1977
K800151 · EMIT TOBRAMYCIN CONTROL
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