Atlas FDA

BD RECYKLEEN SHARPS COLLECTORS

FDA 510(k) clearance K112774 · decided 2012-03-28

Clearance details

K-number
K112774
Device name
BD RECYKLEEN SHARPS COLLECTORS
Applicant
Becton, Dickinson and Company
Decision
Substantially Equivalent
Date received
2011-09-23
Decision date
2012-03-28
Days to decision
187 days
Clearance type
Traditional
Product code
MMK
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Franklin Lakes, NJ, US
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
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
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
BD ONCLARITY HPV ASSAY (P160037/S022)Becton, Dickinson and Company2025-08-25
BD Onclarity HPV Assay (P160037/S023)Becton, Dickinson and Company2025-07-02
Onclarity HPV Assay (P160037/S021)Becton, Dickinson and Company2025-03-12
BD Onclarity™ HPV Assay (P160037/S020)Becton, Dickinson and Company2024-11-05
BD Onclarity HPV Assay (P160037/S017)Becton, Dickinson and Company2024-05-14
BD Onclarity™ HPV Assay (P160037/S019)Becton, Dickinson and Company2024-04-18
BD Onclarity HPV Assay (P160037/S018)Becton, Dickinson and Company2023-11-20
BD Onclarity HPV (P160037/S016)Becton, Dickinson and Company2023-11-15