Cleared Traditional

K833910 - TSH RIA

K833910 is an FDA 510(k) clearance for TSH RIA, manufactured by Syncor Intl. Corp.. The device is a Class 2 Chemistry device with product code ETD cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K833910 · Syncor Intl. Corp. · Chemistry device
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Nov 1983
Decision
8d
Days
Class 2
Risk

K833910 is an FDA 510(k) clearance for the TSH RIA. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Syncor Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1983 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 874.3880 - the FDA in vitro diagnostics and chemistry 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.

View all Syncor Intl. Corp. devices

FDA 510(k) Submission Details - K833910

510(k) Number K833910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1983
Decision Date November 22, 1983
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 Chemistry devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K833910.
TYMPANOSTOMY TUBES-VARIOUS
K833246 · Abco Dealers, Inc. · Jan 1985
UNIFLOW VENT TUBE
K842637 · Richards Medical Co., Inc. · Oct 1984
DONALDSON VENT TUBE
K823910 · Treace Medical, Inc. · Nov 1983
CONCEPT T-TUBE
K832361 · Concept, Inc. · Oct 1983
DONALDSON-TYPE VENT TUBE
K832362 · Concept, Inc. · Oct 1983
SOILEAU TYTAN BOBBIN VENT TUBE
K830584 · Treace Medical, Inc. · Jun 1983