510(k) · Cleared
Recalled · Class II · 2025Pro-Vent, Line Draw, Pulsator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Industries Medical Systems, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 14, 1995 after a 44-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 31 times.
- Decided
- Jul 14, 1995
- Review
- 44 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 31
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK952516 Pro-Vent, Line Draw, PulsatorSmiths Industries Medical Systems, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK981035 Pro-Vent, Pulsator Arterial Blood Sampling SyringesSims Portex, Inc. · 1998 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K981035Pro-Vent, Pulsator Arterial Blood Sampling SyringesSims Portex, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952516 | Pro-Vent, Line Draw, Pulsator | Smiths Industries Medical Systems, Inc. | 1995 | — |
| +1 | K981035 | Pro-Vent, Pulsator Arterial Blood Sampling Syringes | Sims Portex, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981035 | Pro-Vent, Pulsator Arterial Blood Sampling Syringes | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2025 | Class II | Z-1100-2026 | Under Investigation by firm | Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery. |
| Sep 6, 2023 | Class II | Z-0141-2024 | Process control | The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under the FGSKU# 4599P-1 and… |
| Jan 7, 2020 | Class II | Z-1715-2020 | Process control | Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. |
| Jan 7, 2020 | Class II | Z-1716-2020 | Process control | Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers. |
| Jun 22, 2018 | Class II | Z-0843-2019 | Under Investigation by firm | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating. |
| Jun 22, 2018 | Class II | Z-0842-2019 | Under Investigation by firm | The povidone iodine prep pads packaged with the arterial blood sampling kits will not maintain the iodine potency through its labeled 36-month expiration dating. |
| Dec 17, 2014 | Class III | Z-1028-2015 | Employee error | The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit Label is marked with 08-2017 which exceeds the actual expiration date by one year. |
| Nov 22, 2013 | Class II | Z-1187-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1181-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1190-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1186-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1184-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1183-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1188-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1191-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1189-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1182-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1180-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1192-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Nov 22, 2013 | Class II | Z-1185-2014 | Component change control | issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes |
| Sep 9, 2004 | Not classified | Z-0244-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0248-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0249-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0250-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0251-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0254-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0227-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0246-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0247-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0252-05 | Other | Sterility of the device is compromised due to packaging defects |
| Sep 9, 2004 | Not classified | Z-0253-05 | Other | Sterility of the device is compromised due to packaging defects |
The 5 latest of 31 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981035 (Sims Portex, Inc., 1998) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K952516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952516: Pro-Vent, Line Draw, Pulsator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952516
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026