510(k) · Cleared
Recalled · Class II · 2020Combicath Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plastimed Laboratoire Pharmaceutique · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Mar 13, 1998 as substantially equivalent to K923487 (Ballard Medical Products, 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Mar 13, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923487 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK923487 Bal CathBallard Medical Products · 1993
- This deviceK974642 Combicath CatheterPlastimed Laboratoire Pharmaceutique · 1998
- Descendant · cites it directly · 0 of its ownK091250 Diagnostic Catheter SystemCardinal Health, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK024165 Dual-Lumen CatheterBistech, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923487 | Bal Cath | Ballard Medical Products | 1993 | — |
| 0 (this device) | K974642 | Combicath Catheter | Plastimed Laboratoire Pharmaceutique | 1998 | — |
| +1 | K091250 | Diagnostic Catheter System | Cardinal Health, Inc. | 2009 | — |
| +1 | K024165 | Dual-Lumen Catheter | Bistech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 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 EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K923487 | Bal CathSummary page 1…Telescoping Catheter Bronchoscope (flexible or rigid) and Accessories Class II, 21 CFR 874.4680 KTR The COMBICATH Catheter is substantially equivalent to the BAL Cath (K923487), manufactured by Ballard Medical. Other similar devices include the Rigid Suction Tip (K822255), the Argyle Taussig Culture Cath… | 1993 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2020 | Class II | Z-2487-2020 | Process control | Lack of assurance of sterility |
| May 27, 2020 | Class II | Z-2490-2020 | Process control | Lack of assurance of sterility |
| May 27, 2020 | Class II | Z-2491-2020 | Process control | Lack of assurance of sterility |
| May 27, 2020 | Class II | Z-2489-2020 | Process control | Lack of assurance of sterility |
| May 27, 2020 | Class II | Z-2492-2020 | Process control | Lack of assurance of sterility |
| May 27, 2020 | Class II | Z-2488-2020 | Process control | Lack of assurance of sterility |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing
mini bronchoalveolar lavage in mechanically ventilated patients to obtain bronchoalveolar samples
for laboratory testing and diagnosis.
The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as
sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated
patients for laboratory testing and diagnosis.
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/K974642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974642: Combicath Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974642
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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