STATClave G4 Chamber Autoclave— 510(k) K192910

Clearance details

Applicant

Scican , Ltd.

Product code

Code FLE

Device class

Class 2

Regulation

21 CFR 880.6880

Advisory panel

General Hospital

Date received

2019-10-15

Decision date

2020-06-19

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Toronto, CA

• K261055 — AMSCO 700 Steam Sterilizer2026-06-24
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• K252307 — Getinge GSS67N Series Steam Sterilizer2026-01-22
• K250168 — Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer2025-12-30
• K250164 — Cassette Autoclave (ACA5)2025-08-14

• K214057 — STATIM 6000B Vacuum Autoclave2022-03-31
• K210326 — Bravo G4 Chamber Autoclave2021-07-01
• K190062 — STATCLAVE G4 Chamber Autoclave2019-07-26
• K172292 — SALUS - Hygiene Instrument Reprocessing Container2017-11-24
• K112872 — STATIM 2000 G4 CASSETTE2012-07-10

Malfunction

444

Total

444

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2286-2023 — STATCLAVE G4 Chamber Autoclave -Tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. Model: G4 622303Class II·Ongoing·Scican Ltd.·20230622

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192910.