510(k) · Cleared
ClearedPro-Lock CT Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp (Medical Components, Inc.) · PTI Non-Coring (Huber) Needle
Cleared on Apr 26, 2017 as substantially equivalent to K132880 (Medical Components, Inc., 2014) after a 257-day review. Its family tree reaches back 10 generations to 2000. 1 later device descends from it.
- Decided
- Apr 26, 2017
- Review
- 257 days
- Class
- Class II
- Product code
- PTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001901 (2000). 25 ancestors in all, the oldest K863606 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
- 2 generations backK080544 UnassignedMedcomp · 2008
- 1 generation backK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
- This deviceK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
- Descendant · cites it directly · 0 of its ownK171333 20G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) · 2017
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 5 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 4 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
- 2 generations backK080544 UnassignedMedcomp · 2008
- 1 generation backK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
- This deviceK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
Most influential descendants
Showing 1 of 1 · See all- K17133320G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −5 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −4 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −3 | K071846 | Modification to EZ Huber Safety Infusion Set | Pfm Medical, Inc. | 2007 | — |
| −2 | K080544 | Unassigned | Medcomp | 2008 | — |
| −1 | K132880 | Medcomp Power Injectable Safety Huber Needle | Medical Components, Inc. | 2014 | — |
| 0 (this device) | K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017 | — |
| +1 | K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 |
|---|---|---|---|
| * | K132880 | Medcomp Power Injectable Safety Huber NeedleSummary page 4…podermic Needle C.F.R. Section: 21 CFR 880.5570 Class: I Regulation Medical Specialty and Review Panel: General Hospital Predicate Device Information: 510(k) Number: K132880 Trade Name: Medcomp® Power Injectable Safety Huber Needle Device: Non-Coring (Huber) Needle Product Code: PTI C.F.R. Section:… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171333 | 20G x 5/8 Pro-Lock CT Safety Infusion Set | 2017 | 0 |
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 6 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 25 ancestors have a recall of any class.
- Of its descendants, K171333 (Medcomp (Dba Medical Components, Inc.), 2017) has gone furthest, with 0 descendants of its own.
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 Medcomp® Pro-Lock CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp Pro-Lock CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.
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/K162271 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162271: Pro-Lock CT Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162271
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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