510(k) Report

510(k) · Cleared

Cleared

Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with

K072783510(k) TraditionalCleared Nov 30, 200760-day reviewClass II21 CFR 862.1675

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smiths Medical Asd, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

Cleared on Nov 30, 2007 as substantially equivalent to K923090 (Ryan Medical, Inc., 1992) and 2 other predicates after a 60-day review. Its family tree reaches back 1 generation to 1989. 14 later devices descend from it.

Decided
Nov 30, 2007
Review
60 days
Class
Class II
Product code
JKA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K895367 (1989). 3 ancestors in all. 14 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1992: 1 other ancestor1989: 1 other ancestor2008: 1 descendant cleared2015: 1 descendant cleared2013: 1 descendant cleared2020: 2 descendants cleared2024: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2023: 2 descendants cleared2019: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants clearedK895367 · Intravenous Extension Set · Medical Product Specialists · 1989 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 2 descendants K895367 · Intravenous Extension Set · Medical Product Specialists · 1989 · recalled0+5
  1. Root · 1 generation backK895367 Intravenous Extension SetMedical Product Specialists · 1989 · Recalled
  2. This deviceK072783 Saf-T Closed Blood Collection System with Saf-Holder Device, Model…Smiths Medical Asd, Inc. · 2007
  3. Descendant · cites it directly · 13 of its ownK081229 Saf-T Closed Blood Collection System with Saf-Holder Device, with…Smiths Medical Asd, Inc. · 2008
  4. Descendant · 2 generations on · 8 of its ownK142946 TIVAVelano Vascular, Inc. · 2015
  5. Descendant · 3 generations on · 7 of its ownK152924 TIVA¿Velano Vascular · 2016
  6. Descendant · 4 generations on · 6 of its ownK163508 PIVOVelano Vascular · 2017
  7. Descendant · 5 generations on · 5 of its ownK190604 PIVOVelano Vascular · 2019

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008: 12013: 12015: 12016: 12017: 12019: 12020: 22022: 12023: 22024: 12025: 2
2008high 2 (2020) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T WingSmiths Medical Asd, Inc. · 2008 · cites it directly13descendants
  • K142946TIVAVelano Vascular, Inc. · 2015 · 2 generations on8descendants
  • K152924TIVA¿Velano Vascular · 2016 · 3 generations on7descendants
  • K163508PIVOVelano Vascular · 2017 · 4 generations on6descendants
  • K190604PIVOVelano Vascular · 2019 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K895367Intravenous Extension SetMedical Product Specialists19896
0 (this device)K072783Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200…Smiths Medical Asd, Inc.2007—
+1K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G…Smiths Medical Asd, Inc.2008—
+2K142946TIVAVelano Vascular, Inc.2015—
+3K152924TIVA¿Velano Vascular2016—
+4K163508PIVOVelano Vascular2017—
+5K190604PIVOVelano Vascular2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201310
201510
201610
201710
201910
202020
202210
202320
202410
202520
FIG. 1 — Lineage of K072783, 1989–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K923090Saf-T Holder Multi Sample Luer Adapter W/ Blood
Summary page 1
…f-T Closed Blood Collection System® Common Name: Venous Blood Collection Device Classification Name: 862.1675 Blood Specimen Collection Device Predicate Device(s): K923090 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD), hec) Saf-T Holder multi sample Luer adapter with b…
Ryan Medical, Inc.1992—
*K895705Shamrock Safety Blood Collection Set
Summary page 1
…Predicate Device(s): K923090 (Ryan Medical - subsequently acquired from MPS Acacia by Smiths Medical ASD), hec) Saf-T Holder multi sample Luer adapter with blood K895705 (Ryan Medical - subsequently acquired from MIPS Acacia by Smniths Medical ASD, Inc) Shamrock Safety Blood Collection Set K8953…
Ryan Medical, Inc.1989—
*K895367Intravenous Extension Set
Summary page 1
…ulti sample Luer adapter with blood K895705 (Ryan Medical - subsequently acquired from MIPS Acacia by Smniths Medical ASD, Inc) Shamrock Safety Blood Collection Set K895367 (Medical Product Specialists) Intravenous Extension Set MPS Acacia marketed the Saf-T Closed Blood Collection System® under the…
Medical Product Specialists19896

Also cleared against K923090: 1 other device →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081229Saf-T Closed Blood Collection System with Saf-Holder Device, with 21G, 23G, 25G Saf-T WingSmiths Medical Asd, Inc.200813

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K081229 (Smiths Medical Asd, Inc., 2008) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K923090.

How does its category compare?

All JKA devices

JKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JKA

7in 2025

2007: 42008: 22009: 22010: 42012: 12013: 32014: 12015: 12016: 42017: 22018: 12019: 62020: 62021: 42022: 92023: 172024: 62025: 72026 (partial year): 8
2007high 17 (2023) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JKA

115in 2025

2007: 281 days median2010: 28 days median2013: 244 days median2016: 116 days median2019: 181 days median2020: 181 days median2021: 217 days median2022: 164 days median2023: 189 days median2024: 240 days median2025: 115 days median2026 (partial year): 250 days median
2007high 281 (2007) · low 28 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JKA

13in 2025

2007: 32008: 32009: 32010: 42011: 142012: 22013: 12014: 12015: 62016: 12017: 22018: 22019: 92021: 32022: 22023: 22025: 132026 (partial year): 1
2007high 14 (2011) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JKA

6,089in 2025

2007: 732008: 782009: 422010: 372011: 672012: 542013: 332014: 682015: 412016: 652017: 2,0392018: 9,7312019: 6,4692020: 3,7742021: 3,6102022: 3,3752023: 4,4002024: 4,6092025: 6,089
2007high 9,731 (2018) · low 33 (2013)2025

MAUDE reports naming product code JKA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074281373
20082—378
20092—342
2010428437
20110—1467
20121—254
20133244133
20141—168
20151—641
20164116165
20172—22,039
20181—29,731
2019618196,469
2020618103,774
2021421733,610
2022916423,375
20231718924,400
2024624004,609
20257115136,089
202682501—

What is it indicated for?

The Saf-T Closed Blood Collection System® is attached to a peripheral IV catheter at the time of IV catheter placement to allow syringe blood draw and transfer to fill vacuum tubes.

The Saf-T Closed Blood Collection System® is intended for use as syringe blood draw device and sample transfer device from a syringe to a vacuum tube.

Indications for use as stated in the FDA summary.

Also cleared against K923090

1 other device cites the same predicate.

  • K162233Kurin Blood Culture Collection SetPathway, LLC · 2016

More from Smiths Medical Asd, Inc.

70 FDA decisions under this applicant name. See the company

  • K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024
  • K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra…Smiths Medical Asd, Inc. · 2021
  • K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021
  • K192375Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc. · 2020
  • K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018

Recent decisions in JKA

The JKA category page

  • K260857Sol-Guard™ Safety Pull Button Collection Set; Sol-Guard™ XtraThin Safety Pull-Button Blood Collection SetSol-Millennium Medical, Inc. · 2026
  • K252344BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)Becton, Dickinson and Company · 2026
  • K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd. · 2026
  • K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd. · 2026
  • K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and Company · 2026

https://510kreport.com/device/K072783 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072783: Saf-T Closed Blood Collection System with Saf-Holder Device, Model 99200, Saf-T Closed Blood Collection System with.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072783

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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