510(k) · Cleared
ClearedPica Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Jan 15, 2010 as substantially equivalent to K072718 (Penumbra, Inc., 2007) and 4 other predicates after a 23-day review. Its family tree reaches back 5 generations to 2001. 5 later devices descend from it.
- Decided
- Jan 15, 2010
- Review
- 23 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K010954 (2001). 13 ancestors in all, the oldest K010853 (2001). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 4 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 3 generations backK053491 Penumbra Balloon Guide Catheter, Model 7.5FPenumbra, Inc. · 2006
- 2 generations backK070970 Neuron Support Catheter System, Model 5F/6FPenumbra, Inc. · 2007 · Recalled
- 1 generation backK082290 Neuron Delivery Catheter 070Penumbra, Inc. · 2008 · Recalled
- This deviceK093970 Pica CatheterPenumbra, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK122772 Penumbra DDC CathetersPenumbra, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK152202 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm…Tni Manufacturing, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK171672 065 Zenith, 074 ZenithInneuroco, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK173709 Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK161262 Super Distal Access (SDA)Inneuroco, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K122772Penumbra DDC CathetersPenumbra, Inc. · 2012 · cites it directly4descendants
- K152202Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cmTni Manufacturing, Inc. · 2015 · 2 generations on3descendants
- K171672065 Zenith, 074 ZenithInneuroco, Inc. · 2017 · 3 generations on1descendant
- K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cmInneuroco, Inc. · 2018 · 4 generations on0descendants
- K161262Super Distal Access (SDA)Inneuroco, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −4 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −3 | K053491 | Penumbra Balloon Guide Catheter, Model 7.5F | Penumbra, Inc. | 2006 | — |
| −2 | K070970 | Neuron Support Catheter System, Model 5F/6F | Penumbra, Inc. | 2007 | 1 |
| −1 | K082290 | Neuron Delivery Catheter 070 | Penumbra, Inc. | 2008 | 1 |
| 0 (this device) | K093970 | Pica Catheter | Penumbra, Inc. | 2010 | — |
| +1 | K122772 | Penumbra DDC Catheters | Penumbra, Inc. | 2012 | — |
| +2 | K152202 | Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate… | Tni Manufacturing, Inc. | 2015 | — |
| +3 | K171672 | 065 Zenith, 074 Zenith | Inneuroco, Inc. | 2017 | — |
| +4 | K173709 | Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm | Inneuroco, Inc. | 2018 | — |
| +3 | K161262 | Super Distal Access (SDA) | Inneuroco, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 LIT? 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 LIT device
- #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K072718 | Penumbra SystemSummary page 2…(Town, State) ______ Penumbra System Reperliision Penumbra, Inc K(072718 & Catheter Alameda, CA K090752 NeuronTh Intracrani… | 2007 |
| * | K090752 | Penumbra System (Pennumbra Reperfusion Catheter 054), Model PSC054; (Penumbra Separator…Summary page 2…eperliision Penumbra, Inc K(072718 & Catheter Alameda, CA K090752 NeuronTh Intracranial Access Penumbra, Inc K070970, System… | 2009 |
| * | K070970 | Neuron Support Catheter System, Model 5F/6FSummary page 2…Alameda, CA K090752 NeuronTh Intracranial Access Penumbra, Inc K070970, System Alameda, CA K(082290 &… | 2007 |
| * | K082290 | Neuron Delivery Catheter 070Summary page 2…nial Access Penumbra, Inc K070970, System Alameda, CA K(082290 & ____ ___ _______ __ ___ ___ ____ ___ ___ ___… | 2008 |
| * | K083125 | Neuron Select Catheter Size 070Summary page 2…K(082290 & ____ ___ _______ __ ___ ___ ____ ___ ___ ___ K083 125 10.7 Device Description: The PICA Catheter is a variable stiffness catheter with an outer diameter of 0.056in, has… | 2008 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122772 | Penumbra DDC Catheters | 2012 | 4 |
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 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 13 ancestors have a recall of any class.
- Of its descendants, K122772 (Penumbra, Inc., 2012) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K072718.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LIT
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LIT
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LIT
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LIT
2,073in 2025
MAUDE reports naming product code LIT, 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 | 6 | 64 | 0 | 577 |
| 2008 | 8 | 53 | 0 | 513 |
| 2009 | 7 | 29 | 2 | 623 |
| 2010 | 13 | 78 | 1 | 809 |
| 2011 | 10 | 82 | 0 | 857 |
| 2012 | 19 | 29 | 0 | 1,277 |
| 2013 | 14 | 79 | 2 (2) | 1,242 |
| 2014 | 12 | 90 | 3 | 1,178 |
| 2015 | 19 | 112 | 0 | 1,279 |
| 2016 | 11 | 116 | 1 | 1,529 |
| 2017 | 9 | 57 | 0 | 2,081 |
| 2018 | 6 | 118 | 2 | 2,188 |
| 2019 | 4 | 40 | 3 | 2,405 |
| 2020 | 9 | 125 | 0 | 2,443 |
| 2021 | 4 | 61 | 1 | 2,492 |
| 2022 | 8 | 122 | 0 | 2,155 |
| 2023 | 6 | 167 | 0 | 1,807 |
| 2024 | 6 | 43 | 2 | 1,913 |
| 2025 | 3 | 90 | 1 | 2,073 |
| 2026 | 4 | 205 | 0 | — |
What is it indicated for?
The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093970 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093970: Pica Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093970
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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