510(k) · Cleared
Recalled · Class III · 2018Pro-Vent, Pulsator Arterial Blood Sampling Syringes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Apr 21, 1998 as substantially equivalent to K952516 (Smiths Industries Medical Systems, Inc., 1995) after a 33-day review. Its family tree reaches back 1 generation to 1995. It has been recalled once.
- Decided
- Apr 21, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952516 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK952516 Pro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. · 1995 · Recalled
- This deviceK981035 Pro-Vent, Pulsator Arterial Blood Sampling SyringesSims Portex, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952516 | Pro-Vent, Line Draw, Pulsator | Smiths Industries Medical Systems, Inc. | 1995 | 31 |
| 0 (this device) | K981035 | Pro-Vent, Pulsator Arterial Blood Sampling Syringes | Sims Portex, Inc. | 1998 | — |
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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952516 | Pro-Vent, Line Draw, PulsatorSummary page 1…ODUCT CLASS/CLASSIFICATION: Class II, 75 GJE, 21 CFR 862.1675. PREDICATE DEVICE(S): Our Arterial Blood Sampling syringes with Calcium Neutralized Dry Lithium Heparin (K952516). 21 DESCRIPTION: A commercially available hypodermic needle is modified by dispensing sodium heparin into the… | 1995 |
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 13, 2018 | Class III | Z-3196-2018 | Labeling Change Control | The product was mislabeled with the incorrect label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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 arterial blood sampling syringe is intended for sampling of arterial blood for the measurement of pOo, pCO», pH, CO-oximetry, electrolytes (Ca**, Na*, K*, CI-, and Mg+t), Total Magnesium, and the metabolites (Glucose and Lactate).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981035: Pro-Vent, Pulsator Arterial Blood Sampling Syringes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981035
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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