510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010382Substantially Equivalent

100 Series Oxygen Analyzer, Models 1000-E and 1000-I

Sensidyne, Inc., Clearwater FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010382 is the FDA 510(k) clearance record for 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I, a class II device, cleared for Sensidyne, Inc. on under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). FDA records list 4 510(k) clearances for Sensidyne, Inc., from to . As of , FDA records show no recalls naming K010382.

Clearance record

Decision date
Received
(21 days to decision)
Product code
CCL Analyzer, Gas, Oxygen, Gaseous-Phase
Regulation
21 CFR 868.1720
Device class
Class II
Review panel
Anesthesiology
Applicant
Sensidyne, Inc. 16333 Bay Vista Dr., Clearwater FL
510(k) summary
Summary
Third party review
No

Clearances, product code CCL

Trailing 12 months
1 clearance under product code CCL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CCL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260