510(k) · Cleared
ClearedPromisemed Safety Huber Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · PTI Non-Coring (Huber) Needle
Cleared on May 13, 2025 as substantially equivalent to K243332 (Promisemed Hangzhou Meditech Co., Ltd., 2025) after a 29-day review. Its family tree reaches back 12 generations to 2000.
- Decided
- May 13, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- PTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001901 (2000). 39 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- 2 generations backK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
- 1 generation backK243332 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
- This deviceK251138 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 7 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 6 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 5 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- 3 generations backK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- 2 generations backK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
- 1 generation backK243332 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
- This deviceK251138 Promisemed Safety Huber NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −7 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −6 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −5 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −4 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| −3 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… | B.Braun Medical, Inc. | 2017 | — |
| −2 | K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| −1 | K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K243332 | Promisemed Safety Huber NeedlesSummary page 5…II Product Code PTI 3. Legally Marketed Predicate Device [21 CFR 807.92 (a) (3)] Predicate Name Safety Huber Needles 510(k) Number K243332 Product Code PTI Reference Devices No reference devices were used in this submission. 4. Device Descript… | 2025 |
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 25 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 21 of the 39 ancestors have a recall of any class.
How does its category compare?
All PTI devicesPTI Non-Coring (Huber) Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 needle is used to access surgically implanted vascular ports.
Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle
and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick
injuries by sheathing the needle. This device is for adult use only.
In addition, when used with ports that are indicated for power injection of contrast media into the central venous system,
the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251138: Promisemed Safety Huber Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251138
Report an extraction error
Are you the manufacturer?
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