510(k) · Cleared
ClearedTerumo Surshield- Pur Safety I.V. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 26, 2010 as substantially equivalent to K991406 (Terumo Medical Corp., 1999) and 3 other predicates after a 25-day review. Its family tree reaches back 5 generations to 1980. 3 later devices descend from it.
- Decided
- Feb 26, 2010
- Review
- 25 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K801941 (1980). 12 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 4 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 3 generations backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 2 generations backK082362 Surshield Safety I.V. CatheterTerumo Medical Corp. · 2008
- 1 generation backK090973 Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009
- This deviceK100282 Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
- Descendant · cites it directly · 1 of its ownK122544 Terumo Surflash Safety I.V. CatheterTerumo Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK141138 Surflash Safety I.V. CatheterKofu Factory of Terumo Corp. · 2014
- Descendant · cites it directly · 0 of its ownK123267 Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012
Most influential descendants
Showing 3 of 3 · See all- K122544Terumo Surflash Safety I.V. CatheterTerumo Corporation · 2012 · cites it directly1descendant
- K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp. · 2014 · 2 generations on0descendants
- K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −4 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −3 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| −2 | K082362 | Surshield Safety I.V. Catheter | Terumo Medical Corp. | 2008 | — |
| −1 | K090973 | Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) | Terumo Corp. | 2009 | — |
| 0 (this device) | K100282 | Terumo Surshield- Pur Safety I.V. Catheter | Terumo Corp. | 2010 | — |
| +1 | K122544 | Terumo Surflash Safety I.V. Catheter | Terumo Corporation | 2012 | — |
| +2 | K141138 | Surflash Safety I.V. Catheter | Kofu Factory of Terumo Corp. | 2014 | — |
| +1 | K123267 | Surfflash (R) Plus Safety I.V. Catheter | Kofu Factory of Terumo Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterSummary page 2…safety mechanism, design, materials, manufacturing, sterilization, technology/principles of operation, and performance to the following: Polyurethane catheter material -K991406 TERUMO Surflash 1.V. Catheter AND -K082997 TERUMO Hybria Closed System Safety 1.V. Catheter Ethylene Terafluoro Ethylene cathet… | 1999 |
| * | K082997 | Terumo Hybria Closed System Safety I.V. CatheterSummary page 2…uring, sterilization, technology/principles of operation, and performance to the following: Polyurethane catheter material -K991406 TERUMO Surflash 1.V. Catheter AND -K082997 TERUMO Hybria Closed System Safety 1.V. Catheter Ethylene Terafluoro Ethylene catheter material -K082362 TERUMO Surshield Safety… | 2009 |
| * | K082362 | Surshield Safety I.V. CatheterSummary page 2…catheter material -K991406 TERUMO Surflash 1.V. Catheter AND -K082997 TERUMO Hybria Closed System Safety 1.V. Catheter Ethylene Terafluoro Ethylene catheter material -K082362 TERUMO Surshield Safety 1.V. Catheter AND ! A statement of substantially equivalence to another product is required by 21CFR807… | 2008 |
| * | K090973 | Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Summary page 3…42 Fed. Reg. 42,520, et seq. (1977) 2016 -~ Terumo Corporation SPECIAL 510(k) - TERUMO Surshield-PUR Safety 1.V. Catheter Section II. 510(k) Summary -K090973 TERUMO Surshield Safety I.V. Catheter (51mm catheter length) The differences between the devices do not raise any new issues of… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 12 ancestors have a recall of any class.
- Of its descendants, K122544 (Terumo Corporation, 2012) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K991406.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The TERUMO® Surshield®-PUR SAFETY I.V. CATHETER is inserted into the patient’s vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or monitor blood pressure by attaching a monitoring line. The needle-shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
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/K100282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100282: Terumo Surshield- Pur Safety I.V. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100282
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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