# JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

- Device class: 2; regulation: 21 CFR 862.1675; FDA's rule: 510(k) required
- FDA decisions: 240
- 510(k) review time 2021–2025: median 183 days (middle half 123–272)
- Recalls: 97 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 1
- 2019: 6
- 2020: 6
- 2021: 4
- 2022: 9
- 2023: 17
- 2024: 6
- 2025: 7
- 2026: 8

## Most-cited predicates
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set (1998), cited by 12
- K991088: Vacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood Colle (1999), cited by 6
- K200027: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (2020), cited by 5
- K030573: BD Vacutainer Push Button Blood Collection Set, Models 367338, 367344, 367336, 367342, 367335, 367341 (2003), cited by 5
- K172763: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder (2018), cited by 4
- K931367: Vacutainer Brand Luer Adapter (1993), cited by 4
- K940905: Microtainer Brand Tube with Edta (K2) (1994), cited by 4
- K965202: Vacutainer Brand Safety-Lok Blood Collection Set (1997), cited by 3
- K931368: Microtainer Brand Tube with Edta (1993), cited by 3
- K983490: Terumo Venoject,Luer Adapter (1998), cited by 3

Source page: https://510kreport.com/product-code/JKA
Data by year (CSV): https://510kreport.com/product-code/JKA.csv