510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990962Substantially Equivalent

Flosense, Model 29-8010

Sdi Diagnostics, Inc., Easton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K990962 is the FDA 510(k) clearance record for FLOSENSE, MODEL 29-8010, a class II device, cleared for Sdi Diagnostics, Inc. on under FDA product code JAX (Pneumotachometer). FDA records list 10 510(k) clearances for Sdi Diagnostics, Inc., from to . As of , FDA records show no recalls naming K990962.

Clearance record

Decision date
Received
(291 days to decision)
Product code
JAX Pneumotachometer
Regulation
21 CFR 868.2550
Device class
Class II
Review panel
Anesthesiology
Applicant
Sdi Diagnostics, Inc. 10 Hampden Dr., Easton MA
510(k) summary
Statement
Third party review
No

Clearances, product code JAX

Trailing 12 months

FDA records hold no clearances under product code JAX in the trailing twelve months.

FDA records show no clearances under product code JAX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JAX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260