Atlas FDA

Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)

FDA 510(k) clearance K222905 · decided 2023-06-01

Clearance details

K-number
K222905
Device name
Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
Applicant
Ningbo Maxcon Medical Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2022-09-23
Decision date
2023-06-01
Days to decision
251 days
Clearance type
Traditional
Product code
MMK
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Ningbo, CN
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Ningbo Maxcon Medical Technology Co.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Huahong Sharps Container (HHR-I, HHR-II) (K260845)Tianjin Huahong Technology Co., Ltd.2026-08-05
Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong (K253773)Taizhou Huangyan Guanhong Plastic Steel Products Factory2026-05-22
Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) (K253222)Zhejiang Gongdong Medical Technology Co., Ltd.2025-12-22
PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) (K251874)Pureway Compliance, Inc.2025-10-14
Community Containers (Flap and Daisy) (K252637)Keter Canada, Inc.2025-10-14
PureWay 1.4 Quart Sharps Collector (K231484)Pureway Compliance, Inc.2023-09-14
Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 (K222906)Ningbo Maxcon Medical Technology Co., Ltd.2023-06-16
Qlicksmart BladeFlask UNIVERSAL (K213274)Qlicksmart Pty , Ltd.2022-06-22
Promisemed Sharps container (K211890)Promisemed Hangzhou Meditech Co., Ltd.2021-11-17
Nitta M&T Safety Box (K211464)Nitta M&T (Thailand) Co., Ltd.2021-09-14
Tiger Reusable Sharps Container (K203305)International Marketing Specialists, Inc.2021-08-06
Sharps container (K201523)Zhejiang Gongdong Medical Technology Co., Ltd.2020-11-12

Recalls involving this device

No recalls on record reference this clearance.