Atlas FDA

Huahong Sharps Container (HHR-I, HHR-II)

FDA 510(k) clearance K260845 · decided 2026-08-05

Clearance details

K-number
K260845
Device name
Huahong Sharps Container (HHR-I, HHR-II)
Applicant
Tianjin Huahong Technology Co., Ltd.
Decision
Substantially Equivalent
Date received
2026-03-16
Decision date
2026-08-05
Days to decision
142 days
Clearance type
Traditional
Product code
MMK
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Tianjin, CN
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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
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) (K222905)Ningbo Maxcon Medical Technology Co., Ltd.2023-06-01
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.