510(k) · Cleared
ClearedPiccGuard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Piccguard, LLC · PZW Catheter Access Cover, Tamper-Resistant
Cleared on Jan 3, 2020 as substantially equivalent to K172899 (Vygon USA, 2018) after a 245-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Jan 3, 2020
- Review
- 245 days
- Class
- Class II
- Product code
- PZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001901 (2000). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 1 generation backK172899 Vygon PICCsVygon USA · 2018
- This deviceK191195 PiccGuardPiccguard, LLC · 2020
- Descendant · cites it directly · 0 of its ownK220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company · 2022
Most influential descendants
Showing 1 of 1 · See all- K2205073M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −6 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −5 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −4 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −3 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −2 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −1 | K172899 | Vygon PICCs | Vygon USA | 2018 | — |
| 0 (this device) | K191195 | PiccGuard | Piccguard, LLC | 2020 | — |
| +1 | K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 3M Company | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 PZW? 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 PZW device
- #1 K220507 3M Curos Tamper-Evident Device, 3M Curos…score 5.5 · 8 generations · no Class I recall
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.
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 |
|---|---|---|---|
| K220507 | 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large | 2022 | 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 20 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K220507 (3M Company, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PZW devicesPZW Catheter Access Cover, Tamper-Resistant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PZW
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · PZW
Too few PZW 510(k)s in any year since 2007 to give a median.
Recalls per year · PZW
No recall names PZW since 2007.
Adverse event reports per year · PZW
No MAUDE report names PZW since 2007.
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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PICCGuard device is indicated for use as a tamper evident enclosure for the shaft of the catheter and Luer hub with needleless connector attached on medical devices such as PICC lines and other central line catheter ports.
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/K191195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191195: PiccGuard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191195
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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