Cleared Traditional

K973176 - SEIZURE EMERGENCY EQUIPMENT KIT

Also marketed or referenced as:
SEIZURE KIT
K973176 · Lotus Technologies · Anesthesiology device
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Nov 1997
Decision
88d
Days
-
Risk

K973176 is an FDA 510(k) clearance for the SEIZURE EMERGENCY EQUIPMENT KIT.

Submitted by Lotus Technologies (Austin, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel. 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 Lotus Technologies devices

FDA 510(k) Submission Details - K973176

510(k) Number K973176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 25, 1997
Decision Date November 21, 1997
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

KGA Device Classification - Class ,

Product Code KGA
Device Class -