510(k) K952516 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
PRO-VENT, LINE DRAW, PULSATOR
| Applicant | Smiths Industries Medical Systems, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Jul 14, 1995 |
| Received | May 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2026 | ICU Medical Inc. Pulsator Arterial Blood Sampling Kit, Item Numbers
4044EG-1
4080P-2
4084P-1
4080PE
4080PG Open, Classified |
JKA | None listed |
| Oct 20, 2023 | Smiths Medical ASD Inc. Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 Open, Classified |
JKA | None listed |
| Apr 15, 2020 | Smiths Medical ASD, Inc. Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes Terminated |
JKA | None listed |
| Apr 15, 2020 | Smiths Medical ASD, Inc. Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes Terminated |
JKA | None listed |
| Jun 22, 2018 | Smiths Medical ASD Inc. Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, Terminated |
JKA | None listed |
| Jun 22, 2018 | Smiths Medical ASD Inc. Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 407 Terminated |
JKA | None listed |
| Jan 29, 2015 | Smiths Medical ASD, Inc. Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes.
Reorder Number: G1392
Product Usage: The Arterial Blood Sampling Kit is intended for Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, 22g x 1 needle, and Point-Lok needle safety device
Arterial Blood Sampling Line D Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagno Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and ice bag
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap and 6 mL Luer slip syringe
Arterial Blood Sampling Line Draw Syringes are Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro device
Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnost Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Europe only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device (for sale in Japan only)
Arterial Blood Sampling Line Draw Syringes are sterile, single-use Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, syringe tip cap, and 5 mL Luer lock syringe
Arterial Blood Sampling Line Draw Syringes are s Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro devices and (2) Needle-Pro Devices with 22G x 1needles
Arterial Blood Sampling Line Terminated |
JKA | None listed |
| Mar 12, 2014 | Smiths Medical ASD, Inc. G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device, Needle-Pro Device and 23G x 1 needle
Arterial Blood Sampling Line Draw Syringes are sterile, Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Catalog Number: 4589P-1 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1481 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1488 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1515 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1540 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1554 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1560 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1562 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1576 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1615 Terminated |
JKA | None listed |
| Nov 24, 2004 | Smiths Medical ASD, Inc. Portex Custom Pro-Vent Arterial Blood Sampling Kit
Catalog Number: G1696 Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.