JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection

Device class

Class II

Regulation 862.1675

Total clearances

2020-01-21 → 2026-06-02

Last 12 months

Unique sponsors

Classification details

Medical specialty

Clinical Chemistry

Review panel

Regulation number

862.1675

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Becton, Dickinson and Company	16	4	2026-04-15
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.	4	0	2023-03-24
Sb-Kawasumi Laboratories, Inc.	3	0	2023-06-01
Magnolia Medical Technologies	3	1	2025-09-25
Becton Dickinson Infusion Therapy Systems, Inc.	2	0	2025-02-27
Velano Vascular	2	0	2022-10-03
Kurin, Inc.	2	0	2023-04-28
Jiangsu Caina Medical Co.,Ltd	2	0	2024-03-07
Sol-Millennium Medical, Inc.	2	0	2025-04-30
Owen Mumford, Ltd.	1	0	2023-06-30
The Monarch Company	1	0	2023-12-04
Avia Vascular	1	0	2022-07-14
Lifeoutcomes, LLC	1	0	2024-01-26
Zhejiang Kindly Medical Device Co., Ltd.	1	1	2026-06-02
Retractable Technologies, Inc.	1	0	2021-04-09
Nsp Tech Pte, Ltd.	1	0	2020-04-21
Jiangsu Kangbao Medical Equipment Co., Ltd.	1	0	2023-12-22
Chirana T. Injecta	1	0	2021-07-21
Yangzhou Medline Industry, Co., Ltd.	1	0	2023-07-07
Jiangsu Micsafe Medical Technology Co., Ltd.	1	0	2021-11-04
Innovative Medical Technologies, Inc.	1	0	2023-09-29
Eclipse Medcorp, LLC	1	0	2022-10-26
Jiangsu Rongye Technology Co., Ltd.	1	0	2023-10-27
Promisemed Hangzhou Meditech Co., Ltd.	1	0	2025-06-04
Greiner Bio-One North America, Inc.	1	0	2024-07-19

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
36415	CPT	—	Medium	Venipuncture supply code; blood collection tube/vial is component of collection service
P9000	HCPCS	—	Low	Discontinued code; check current HCPCS for blood collection supplies

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-02	K252899	Zhejiang Kindly Medical Device Co., Ltd.	Female Culture Device; Male Culture Device; Transfer Device; Access Device
2026-04-15	K260128	Becton, Dickinson and Company	BD Preset and BD A-Line Arterial Blood Collection Syringes
2026-04-10	K252506	Becton, Dickinson and Company	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
2026-04-10	K252378	Becton, Dickinson and Company	BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
2026-03-13	K252040	Becton, Dickinson and Company	BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
2025-09-25	K251812	Magnolia Medical Technologies	Steripath® Flow Blood Collection System
2025-07-03	K243207	Becton, Dickinson and Company	BD Vacutainer® Eclipse Blood Collection Needle
2025-06-04	K250961	Promisemed Hangzhou Meditech Co., Ltd.	Blood collection tube holders
2025-05-23	K244047	Venocare, Inc.	Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)
2025-04-30	K250907	Sol-Millennium Medical, Inc.	Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
2025-03-21	K243649	Becton, Dickinson and Company	BD Vacutainer® Multiple Sample Luer Adapter
2025-02-27	K241586	Becton Dickinson Infusion Therapy Systems, Inc.	PIVO Pro Needle-free Blood Collection Device
2024-11-01	K242320	Becton, Dickinson and Company	BD Vacutainer® One Use Holder
2024-07-19	K233979	Greiner Bio-One North America, Inc.	VACUETTE® QUICKSHIELD Complete (Plus)
2024-03-07	K232781	Jiangsu Caina Medical Co.,Ltd	Safety Sliding Blood Collection Set
2024-02-02	K231373	Becton, Dickinson and Company	BD Vacutainer® K2 EDTA Blood Collection Tubes
2024-01-26	K231282	Lifeoutcomes, LLC	LifeOutcomes C-Quest Blood Culture Sampling Device
2024-01-19	K231237	Becton, Dickinson and Company	BD Vacutainer® Fluoride Blood Collection Tubes
2023-12-22	K232881	Jiangsu Kangbao Medical Equipment Co., Ltd.	Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
2023-12-20	K230855	Becton, Dickinson and Company	BD Vacutainer® Serum Separator (SST) Blood Collection Tubes
2023-12-04	K232308	The Monarch Company	Monarch Blood Collection Set
2023-12-01	K230391	Becton, Dickinson and Company	BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube
2023-10-27	K213146	Jiangsu Rongye Technology Co., Ltd.	Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen
2023-09-29	K220458	Innovative Medical Technologies, Inc.	UltraFlo-R Push Button Blood Collection Set
2023-09-28	K230865	Becton Dickinson Infusion Therapy Systems, Inc.	PIVO Pro Needle-free Blood Collection Device