510(k) · Cleared
ClearedPPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI Pressure Injectable Safety Huber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perouse Medical · FPA Set, Administration, Intravascular
Cleared on May 2, 2012 as substantially equivalent to K082306 (C.R. Bard, Inc., 2008) and 1 other predicate after a 96-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- May 2, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K001901 (2000). 25 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 2 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 1 generation backK082306 Powerloc Clear Safety Infusion SetC.R. Bard, Inc. · 2008
- This deviceK120261 PPS PI Pressure Injectable Safety Huber Needle Without Lateral…Perouse Medical · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −3 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −2 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −1 | K082306 | Powerloc Clear Safety Infusion Set | C.R. Bard, Inc. | 2008 | — |
| 0 (this device) | K120261 | PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site… | Perouse Medical | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K082306 | Powerloc Clear Safety Infusion SetSummary page 1…set Name - Classification set, administration, intravascular Name Legally -Power Loc safety infusion set, Bard access systems (510(k) no K082306). The marketed indications for use are the same as the PPS P1o Pressure Injectable Safety Huber predicate Ne… | 2008 |
| * | K063631 | Polyperf / Polyperf Safe Our reading of the summary gave K053631, FDA’s number for Contour Transtar Curved Cutter Stapler Set (Ethicon Endo-Surgery, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Polyperf Safe”. | 2007 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 12 of the 25 ancestors have a recall of any class.
- 1 other device also cites its predicate K082306.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The PPS PI* curved safety Huber needle is indicated for:
Administration or withdrawal of fluids through implanted ports.
-Pressure injection of contrast media into the central venous system only with an implantable infusion port that is also indicated for pressure injection.
-The maximum recommended infusion rate at 11,8 cP is
- 5 mL/sec. for 19 Ga. needle
- 5 mt/sec. for 20 Ga. needle
- 2 mt/sec. for 22 Ga. needle.
-The PPS P1' Curved Safety Huber needle is indicated to prevent blood-borne pathogen exposures caused by accidental needle punctures. The PPS Pl* Curved Safety Huber needle does not protect against other routes of blood-borne pathogen transmission.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120261: PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI Pressure Injectable Safety Huber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120261
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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