510(k) · Cleared
Recalled · 2006Safepico
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 22, 2005 as substantially equivalent to K962158 (Radiometer America, Inc., 1996) after a 158-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Apr 22, 2005
- Review
- 158 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896514 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962158 | Pico Models 30, 50, 70Summary page 1…safePICO Common name: Vented Arterial Blood Sampler Classification Name: Piston Syringe Predicate Devices PICO Arterial Blood Sampler (K962158) and PRO-VENT with NEEDLE-PRO (K011925). Device Description… | 1996 |
| Kept off the family tree | K011925 | FDA’s K011925 is Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… Our reading of the summary gave K011925, FDA’s number for Hypodermic Needle-Pro Needle with Needle Protection… (Sims Portex, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “PRO-VENT with NEEDLE-PRO”. Kept off the family tree. Summary page 1…Vented Arterial Blood Sampler Classification Name: Piston Syringe Predicate Devices PICO Arterial Blood Sampler (K962158) and PRO-VENT with NEEDLE-PRO (K011925). Device Description PICO70 The barrel and p… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 18, 2006 | Not classified | Z-1443-06 | Other | Leaking Tip Caps-Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The safePICO Arterial Blood Sampler is a preheparinized, electrolyte balanced, arterial blood sampler for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analyses. The safePICO is a vented sampler for sample volumes in the range from 0.7 to 1.5 mL. The safePICO includes a vented tip cap allowing the sampler to be vented after the appliance of the tip cap and may include a needle shield device to prevent a user from accidental needle stick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043143: Safepico.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043143
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026