510(k) · Cleared
Cleared3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · PZW Catheter Access Cover, Tamper-Resistant
Cleared on May 23, 2022 as substantially equivalent to K191195 (Piccguard, LLC, 2020) after a 90-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- May 23, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- PZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001901 (2000). 9 ancestors in all. 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 backK172899 Vygon PICCsVygon USA · 2018
- 1 generation backK191195 PiccGuardPiccguard, LLC · 2020
- This deviceK220507 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large3M Company · 2022
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 | K172899 | Vygon PICCs | Vygon USA | 2018 | — |
| −1 | K191195 | PiccGuard | Piccguard, LLC | 2020 | — |
| 0 (this device) | 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 |
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 K191195 PiccGuardscore 3.4 · 7 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K191195 | PiccGuardSummary page 4…long-term intravascular catheter [21 CFR § 880.5970, PZW] Secondary Product Codes: FPA, LJS Predicate Device PICCGuard, K191195, 21 CFR § 880.5970, PZW, Secondary Product Codes (LJS, FPA) Indications for Use 3M™ Curos™ Tamper-Evident Device: The 3M™ Curo… | 2020 |
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 22 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 9 ancestors have a recall of any class.
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. 2022, 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?
3M™ Curos™ Tamper-Evident Device: The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device. 3M™ Curos™ Tamper-Evident Device, Large: The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover…
Read the full statement (108 words)
3M™ Curos™ Tamper-Evident Device:
The 3M™ Curos™ Tamper-Evident Device is intended to be used as a tamper-evident cover for vascular access devices for IV access points including needleless connectors and Y-sites on IV tubing. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
3M™ Curos™ Tamper-Evident Device, Large:
The 3M™ Curos™ Tamper-Evident Device, Large is intended to be used as a tamper-evident cover on vascular access device needleless connectors including Y-sites on IV tubing, and infusing connections, providing visual indication of attempts to tamper with or remove the device. This device provides visual indication to suspect tampering. This is not a tamper-proof device.
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/K220507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220507: 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220507
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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