510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221309Substantially Equivalent

AI100 with Shonit

Sigtuple Technologies Pvt., Ltd., Bangalore, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221309 is the FDA 510(k) clearance record for AI100 with Shonit, a class II device, cleared for Sigtuple Technologies Pvt. , Ltd. on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list one 510(k) clearance for Sigtuple Technologies Pvt. , Ltd. As of , FDA records show no recalls naming K221309.

Clearance record

Decision date
Received
(502 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Sigtuple Technologies Pvt. , Ltd. First Floor, L-162, 14th Cross Rd., Sector 6, Hsr Layout, Bangalore, IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOY

Trailing 12 months

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

FDA records show no clearances under product code JOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOY, 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