Steripath Gen2 Blood Collection System— 510(k) K192247
Substantially EquivalentMagnolia Medical Technologies, Inc.
FDA 510(k) clearance K192247 for Steripath Gen2 Blood Collection System, Substantially Equivalent on 2020-02-28. Applicant: Magnolia Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Magnolia Medical Technologies, Inc.
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seattle, WA, US
Recent devices under product code JKA
view all- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K252378 — BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
More clearances from Magnolia Medical Technologies, Inc.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192247
K-number listed on FDA's recall record- Z-0318-2022 — The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck
- Z-2393-2021 — Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.