510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241036Substantially Equivalent

Autoclave Indicator Tape; EO Indicator Tape

Jiangmen New Era External Use Drug Co., Ltd., Jiangmen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241036 is the FDA 510(k) clearance record for Autoclave Indicator Tape; EO Indicator Tape, a class II device, cleared for Jiangmen New Era External Use Drug Co., Ltd. on under FDA product code JOJ (Indicator, Physical/Chemical Sterilization Process). FDA records list one 510(k) clearance for Jiangmen New Era External Use Drug Co., Ltd. As of , FDA records show no recalls naming K241036.

Clearance record

Decision date
Received
(245 days to decision)
Product code
JOJ Indicator, Physical/Chemical Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Jiangmen New Era External Use Drug Co., Ltd. No 8 Beiyuan Rd., Jianghai Dist., Jiangmen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOJ

Trailing 12 months
3 clearances under product code JOJ in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOJ, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260