510(k) · Cleared
ClearedSurfflash (R) Plus Safety I.V. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kofu Factory of Terumo Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Nov 2, 2012 as substantially equivalent to K100282 (Terumo Corp., 2010) and 4 other predicates after a 14-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Nov 2, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K801941 (1980). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 5 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 4 generations backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- 3 generations backK082362 Surshield Safety I.V. CatheterTerumo Medical Corp. · 2008
- 2 generations backK090973 Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009
- 1 generation backK100282 Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
- This deviceK123267 Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −5 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −4 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| −3 | K082362 | Surshield Safety I.V. Catheter | Terumo Medical Corp. | 2008 | — |
| −2 | K090973 | Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) | Terumo Corp. | 2009 | — |
| −1 | K100282 | Terumo Surshield- Pur Safety I.V. Catheter | Terumo Corp. | 2010 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1986 | 2 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 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? (5)
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 |
|---|---|---|---|
| * | K100282 | Terumo Surshield- Pur Safety I.V. CatheterSummary page 3…alize flashback detection through the groove indicating that there is confirmation of vessel entry is the same as the TERUMOO Surshieldo-PIJR Safety INV. Catheter (K100282) and TERIJMO®, SIJRFLASH® TVX Catheter (K99 1406). Material The stainless steel cannula is placed in the catheter to ma… | 2010 |
| * | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterSummary page 3…icating that there is confirmation of vessel entry is the same as the TERUMOO Surshieldo-PIJR Safety INV. Catheter (K100282) and TERIJMO®, SIJRFLASH® TVX Catheter (K99 1406). Material The stainless steel cannula is placed in the catheter to maintain rigidity and is withdrawn after the cathet… | 1999 |
| * | K110443 | BD Insyte Autoguard BCSummary page 7…LI.K00282 TERUMO® Surshield®-PUR Safety I.V. Catheter (Terumo Corporation) 2. K991406 TERUMO® SURFLASH-1 l.V Catheter (Terumo Corporation) 3. K110443 BDlInsyteAutoguard BC shielded I. Catheter (Becton Dickinson) 4. K971339 BD Insyte T M Autoguard T M shielded I.V Catheter… | 2011 |
| * | K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersSummary page 7…orporation) 2. K991406 TERUMO® SURFLASH-1 l.V Catheter (Terumo Corporation) 3. K110443 BDlInsyteAutoguard BC shielded I. Catheter (Becton Dickinson) 4. K971339 BD Insyte T M Autoguard T M shielded I.V Catheter (Becton Dickinson) 4. K923 702 Saf-T-lntima Closed IV Catheter System (Bec… | 1997 |
| * | K923702 | Intima Point Guard Intravascular CatheterSummary page 7…3. K110443 BDlInsyteAutoguard BC shielded I. Catheter (Becton Dickinson) 4. K971339 BD Insyte T M Autoguard T M shielded I.V Catheter (Becton Dickinson) 4. K923 702 Saf-T-lntima Closed IV Catheter System (Becton Dickinson) Comparison of the intended use/indication for use statements and… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 5 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K100282.
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. 2012, 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 SLJRFLASHO Plus Safety J.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenouslyj or monitor blood pressure by attaching a monitoring line. The needle shaft cover and tip shield feature aids mn the prevention of needle slick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being inifused and duration of therapy. The 18 to 22 gauge catheters are suitable for use with power injectors rated for a maximum of 325 psi.
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/K123267 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123267: Surfflash (R) Plus 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/K123267
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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