510(k) · Cleared
ClearedArgyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sherwood Medical Co. · FHO Pneumoperitoneum Needle
Cleared on Aug 5, 1996 as substantially equivalent to K934428 (Sherwood Medical Co., 1993) after a 175-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 5, 1996
- Review
- 175 days
- Class
- Class II
- Product code
- FHO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934428 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK934428 Argyle Turkel Safety Pneumothorax Procedure TraySherwood Medical Co. · 1993
- This deviceK960574 Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray…Sherwood Medical Co. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934428 | Argyle Turkel Safety Pneumothorax Procedure Tray | Sherwood Medical Co. | 1993 | — |
| 0 (this device) | K960574 | Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic… | Sherwood Medical Co. | 1996 | — |
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 FHO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K934428 | Argyle Turkel Safety Pneumothorax Procedure TraySummary page 1…cnatal/Pediatric Thoracic Catheter Insertion Tray is substantially equivalent to Sherwood Medical'’s currently marketed Argyle Turkel Safety Pneumothorax Procedure Tray (K934428) in that both share the same basic 1) components, 2) intended use and 3) the catheters are introduced in the chest via a trocar.… | 1993 |
| * | — | Argyle Trocar Catheters & Trocar Catheter Kits Named without a submission number |
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?
- Its one ancestor has no recall.
How does its category compare?
All FHO devicesFHO Pneumoperitoneum Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FHO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · FHO
Too few FHO 510(k)s in any year since 2007 to give a median.
Recalls per year · FHO
No recall names FHO since 2007.
Adverse event reports per year · FHO
1in 2025
MAUDE reports naming product code FHO, 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 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 6 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neonatal/Pediatric Thoracic Catheter is a sterile,
single use indwelling catheter, used to create a patent open
passageway between the chest cavity and atmosphere or a Chest
Drainage Unit (CDU). The catheter is intended to prevent
pressure from developing in the chest, averting lung collapse and
providing a means for fluid to drain from the chest cavity.
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/K960574 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960574: Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray and Thoracic Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960574
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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