510(k) · Cleared
ClearedSurecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · PTI Non-Coring (Huber) Needle
Cleared on Nov 3, 2017 as substantially equivalent to K073050 (Specialized Health Products International, Inc., 2008) after a 221-day review. Its family tree reaches back 9 generations to 2000. 6 later devices descend from it.
- Decided
- Nov 3, 2017
- Review
- 221 days
- Class
- Class II
- Product code
- PTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K001901 (2000). 36 ancestors in all, the oldest K863606 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- This deviceK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021
- Descendant · 2 generations on · 1 of its ownK243332 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK254095 25G Huber NeedleMartech Medical Products · 2026
- Descendant · 3 generations on · 0 of its ownK251138 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- This deviceK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · cites it directly2descendants
- K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · cites it directly2descendants
- K243332Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025 · 2 generations on1descendant
- K25409525G Huber NeedleMartech Medical Products · 2026 · 2 generations on0descendants
- K251138Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −2 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −1 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| 0 (this device) | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… | B.Braun Medical, Inc. | 2017 | — |
| +1 | K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| +1 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
| +2 | K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025 | — |
| +2 | K254095 | 25G Huber Needle | Martech Medical Products | 2026 | — |
| +3 | K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 PTI? 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 PTI device
- #1 K254095 25G Huber Needlescore 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K073050 | Safestep Max Power-Injectable Infusion SetSummary page 4…TI, 880.5570 PREDICATE DEVICE: SafeStep MAX Power-Injectable Infusion Set, Specialized Health Products International Inc., K073050, Class II, FPA, 880.5440 DESCRIPTION: The Surecan Safety II power-injectable safety non-coring… | 2008 |
What descends from it? (6)
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 17 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 21 of the 36 ancestors have a recall of any class.
- Of its descendants, K230715 (Promisemed Hangzhou Meditech Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K073050.
How does its category compare?
All PTI devicesPTI Non-Coring (Huber) Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PTI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTI
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PTI
No recall names PTI since 2007.
Adverse event reports per year · PTI
33in 2025
MAUDE reports naming product code PTI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 5 | 221 | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 2 | — | 0 | 17 |
| 2022 | 1 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 9 |
| 2024 | 1 | — | 0 | 36 |
| 2025 | 3 | 120 | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast…
Read the full statement (121 words)
The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media.
For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge and 20 gauge needles and 2mL/s for the 22 gauge needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170897
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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