510(k) · Cleared
Cleared20G x 5/8 Pro-Lock CT Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp (Dba Medical Components, Inc.) · PTI Non-Coring (Huber) Needle
Cleared on Jul 18, 2017 as substantially equivalent to K162271 (Medcomp (Medical Components, Inc.), 2017) after a 71-day review. Its family tree reaches back 11 generations to 2000.
- Decided
- Jul 18, 2017
- Review
- 71 days
- Class
- Class II
- Product code
- PTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K001901 (2000). 26 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK080544 UnassignedMedcomp · 2008
- 2 generations backK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
- 1 generation backK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
- This deviceK171333 20G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) · 2017
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 6 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 5 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
- 3 generations backK080544 UnassignedMedcomp · 2008
- 2 generations backK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
- 1 generation backK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
- This deviceK171333 20G x 5/8 Pro-Lock CT Safety Infusion SetMedcomp (Dba Medical Components, Inc.) · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −6 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −5 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −4 | K071846 | Modification to EZ Huber Safety Infusion Set | Pfm Medical, Inc. | 2007 | — |
| −3 | K080544 | Unassigned | Medcomp | 2008 | — |
| −2 | K132880 | Medcomp Power Injectable Safety Huber Needle | Medical Components, Inc. | 2014 | — |
| −1 | K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K162271 | Pro-Lock CT Safety Infusion SetSummary page 4…Single Lumen Hypodermic Needle 21 CFR 880.5570 Il General Hospital Predicate Device Information: 510(k) Number: Trade Name: Device: Product Code: C.F.R. Section: K162271 Pro-Lock™ CT Safety Infusion Set Non-Coring (Huber) Needle PTI 21 CFR 880.5570 6-1 Medcomp®: 20G x 5/8” Pro-Lock™ CT Safety… | 2017 |
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 17 years and passes through 7 companies; a new generation was cleared every 12 months on median.
- 11 of the 26 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. 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 sample 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/K171333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171333: 20G x 5/8 Pro-Lock CT Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171333
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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