MAXIMA-10

FDA 510(k) K911206 · Stirn Industries

Substantially Equivalent

510(k) numberK911206

Submission

Device name
MAXIMA-10
Applicant
Stirn Industries
Dayton, NJ, US
Received
March 19, 1991
Decision date
November 29, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FLE – Sterilizer, Steam
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6880
Specialty
General Hospital

Other 510(k)s with product code FLE

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K261055AMSCO 700 Steam SterilizerFLE · Traditional STERIS Corporation06/24/2026SE
K260254Enbio PROFLE · Traditional Enbio Group AG02/26/2026SE
K252307Getinge GSS67N Series Steam SterilizerFLE · Traditional Maquet GmbH (A Getinge Group Company)01/22/2026SE
K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerFLE · Traditional Lucas Lifecare12/30/2025SE
K250164Cassette Autoclave (ACA5)FLE · Traditional Guangzhou Ajax Medical Equipment Co., Ltd.08/14/2025SE
K243994Steam Sterilizer (2545D)FLE · Traditional Ningbo Ican Machines Co., Ltd.06/06/2025SE
K243801FRONT-LINE Field Sterilizer (FL135)FLE · Special Fort Defiance Industries, LLC03/07/2025SE
K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerFLE · Traditional Midmark Corporation04/04/2024SE
K233504Lexa MINI (RIS-303, RIS-305)FLE · Traditional W&H Sterilization S.R.L.02/08/2024SE
K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)FLE · Abbreviated Primus Sterilizer Company, LLC12/19/2023SE

More from Primus Sterilizer Company, LLC

510(k)DeviceDecision
K920288Powered Vacuum Aspirator 1110-G-062JCX · Traditional 06/29/1992SE
K920287Powered Vacuum Aspirator 1110-G-030JCX · Traditional 06/29/1992SE

Questions and answers

When was MAXIMA-10 cleared by the FDA?

MAXIMA-10 (K911206) received a 510(k) decision of Substantially Equivalent on November 29, 1991, 255 days after the submission was received.

What is the product code of K911206?

The FDA product code is FLE – Sterilizer, Steam, a Class II (moderate risk) device regulated under 21 CFR 880.6880.