Cleared Traditional

SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606 (K981800) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981800 · Equal Diagnostics, Inc. · Toxicology device
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Jul 1998
Decision
46d
Days
Class 2
Risk

K981800 is an FDA 510(k) clearance for the SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606. Classified as Hysteroscope (and Accessories) (product code HIH), Class II - Special Controls.

Submitted by Equal Diagnostics, Inc. (Exton, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 884.1690 - 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.

View all Equal Diagnostics, Inc. devices

Submission Details

510(k) Number K981800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date July 06, 1998
Days to Decision 46 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIH Hysteroscope (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1690
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.

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All 170
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