510(k) · Cleared
ClearedIntima Point Guard Intravascular Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vascular Access, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Sep 22, 1993 after a 425-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 22, 1993
- Review
- 425 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK923702 Intima Point Guard Intravascular CatheterBecton Dickinson Vascular Access, Inc. · 1993
- Descendant · cites it directly · 4 of its ownK082997 Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp. · 2009
- Descendant · 2 generations on · 3 of its ownK100282 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 5 of 5 · See all- K082997Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp. · 2009 · cites it directly4descendants
- K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010 · 2 generations on3descendants
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K923702 | Intima Point Guard Intravascular Catheter | Becton Dickinson Vascular Access, Inc. | 1993 | — |
| +1 | K082997 | Terumo Hybria Closed System Safety I.V. Catheter | Terumo Medical Corp. | 2009 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K082997 (Terumo Medical Corp., 2009) has gone furthest, with 4 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K923702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923702: Intima Point Guard Intravascular Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923702
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026