510(k) · Cleared
ClearedCopperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mallinckroot, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal
Cleared on Apr 16, 1999 as substantially equivalent to K965183 (Guidant Corp., 1997) and 5 other predicates after a 168-day review. Its family tree reaches back 2 generations to 1992. 2 of the 21 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it.
- Decided
- Apr 16, 1999
- Review
- 168 days
- Class
- Class II
- Product code
- LIT
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K920547 (1992). 8 ancestors in all, the oldest K904984 (1991). 12 later devices descend from it, 2 citing it directly. 2 of the 21 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK920547 Ultra-ThinBoston Scientific Corp · 1992
- 1 generation backK965183 Vantage Peripheral Dilatation CatheterGuidant Corp. · 1997
- This deviceK983830 Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta CatheterMallinckroot, Inc. · 1999
- Descendant · cites it directly · 10 of its ownK022212 Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003
- Descendant · 2 generations on · 6 of its ownK040014 Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and…Portex, Ltd. · 2004
- Descendant · 2 generations on · 5 of its ownK041348 Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial…Smiths Medical · 2004 · Recalled
- Descendant · 3 generations on · 2 of its ownK133597 Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue…Cook, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 2 of its ownK041044 Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K022212Portex Percutaneous Dilatational Tracheostomy KitsMentor Medical Limited · 2003 · cites it directly10descendants
- K040014Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft Introducers…Portex, Ltd. · 2004 · 2 generations on6descendants
- K041348Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators or Single…Smiths Medical · 2004 · 2 generations on5descendants
- K133597Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino Percutaneous…Cook, Inc. · 2014 · 3 generations on2descendants
- K041044Ciaglia Cheetah Percutaneous Tracheostomy Introducer SetCook, Inc. · 2004 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K920547 | Ultra-Thin | Boston Scientific Corp | 1992 | — |
| −1 | K965183 | Vantage Peripheral Dilatation Catheter | Guidant Corp. | 1997 | — |
| 0 (this device) | K983830 | Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter | Mallinckroot, Inc. | 1999 | — |
| +1 | K022212 | Portex Percutaneous Dilatational Tracheostomy Kits | Mentor Medical Limited | 2003 | — |
| +2 | K040014 | Percutaneous Dilation Tracheostomy Kit with Single Stage Dilator and Soft… | Portex, Ltd. | 2004 | — |
| +2 | K041348 | Portex Ultraperc Percutaneous Dilation Tracheostomy Kit_with Serial Dilators… | Smiths Medical | 2004 | 1 |
| +3 | K133597 | Ciaglia Percutaneous Tracheostomy Introducer Set/Tray, Ciaglia Blue Rhino… | Cook, Inc. | 2014 | 1 |
| +2 | K041044 | Ciaglia Cheetah Percutaneous Tracheostomy Introducer Set | Cook, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 1 |
| 2019 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K965183 | Vantage Peripheral Dilatation CatheterSummary page 1…V (74) LIT Class II (performance standards) 21 CFR 870.4475 d. Identification of Predicate Device(s): 510(Kk) # Advanced Cardiovascular (ACS) Vantage Dilatation Catheter K965183 Bard Tru-Trac Peripheral Balloon Dilatation Catheter K960517 MediTech Ultra-Thin Balloon Dilatation Catheter K924320 Peripheral S… | 1997 |
| * | K960517 | Bard Tru-Trac Peripheral Balloon Dilatation CatheterSummary page 1…. Identification of Predicate Device(s): 510(Kk) # Advanced Cardiovascular (ACS) Vantage Dilatation Catheter K965183 Bard Tru-Trac Peripheral Balloon Dilatation Catheter K960517 MediTech Ultra-Thin Balloon Dilatation Catheter K924320 Peripheral Systems (PSG) Advance 418 Dilatation Catheter K904984 MediTech… | 1996 |
| * | K924320 | Ultra Thin Balloon Dilatation CatheterSummary page 1…ced Cardiovascular (ACS) Vantage Dilatation Catheter K965183 Bard Tru-Trac Peripheral Balloon Dilatation Catheter K960517 MediTech Ultra-Thin Balloon Dilatation Catheter K924320 Peripheral Systems (PSG) Advance 418 Dilatation Catheter K904984 MediTech Symmetry Balloon Dilatation Catheter K953602 MediTech S… | 1993 |
| * | K904984 | Advance 418(TM)Summary page 1…Tru-Trac Peripheral Balloon Dilatation Catheter K960517 MediTech Ultra-Thin Balloon Dilatation Catheter K924320 Peripheral Systems (PSG) Advance 418 Dilatation Catheter K904984 MediTech Symmetry Balloon Dilatation Catheter K953602 MediTech Sub-4 Balloon Dilatation Catheter K924047 e. Intended use: The Ma… | 1991 |
| * | K953602 | Symmetry Small Vessel Balloon Dilatation CatheterSummary page 1…17 MediTech Ultra-Thin Balloon Dilatation Catheter K924320 Peripheral Systems (PSG) Advance 418 Dilatation Catheter K904984 MediTech Symmetry Balloon Dilatation Catheter K953602 MediTech Sub-4 Balloon Dilatation Catheter K924047 e. Intended use: The Mallinckrodt Peripheral Dilatation Catheter is intended… | 1995 |
| * | K924047 | Sub-4 Small Vessel Balloon Dilatation CatheterSummary page 1…K924320 Peripheral Systems (PSG) Advance 418 Dilatation Catheter K904984 MediTech Symmetry Balloon Dilatation Catheter K953602 MediTech Sub-4 Balloon Dilatation Catheter K924047 e. Intended use: The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transiuminal Angioplasty (P… | 1992 |
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation…Smiths Medical Asd, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
- K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K022212 (Mentor Medical Limited, 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All LIT devicesLIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.
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/K983830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983830: Copperhead 5 FR. Pta Catheter, Finch 4 FR. Pta Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983830
Report an extraction error
Are you the manufacturer?
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