510(k) · Decided
DecidedBal Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ballard Medical Products · KTR Tube, Aspirating, Bronchoscope, Rigid
Cleared on Jul 30, 1993 after a 380-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jul 30, 1993
- Review
- 380 days
- Class
- Class II
- Product code
- KTR
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 4 citing it directly.
- This deviceK923487 Bal CathBallard Medical Products · 1993
- Descendant · cites it directly · 4 of its ownK960880 Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996
- Descendant · 2 generations on · 3 of its ownK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- Descendant · cites it directly · 2 of its ownK974642 Combicath CatheterPlastimed Laboratoire Pharmaceutique · 1998 · Recalled
- Descendant · cites it directly · 1 of its ownK112562 Bal Cath Bronchial Aspirate Sampling CatheterKimberly-Clark · 2011
- Descendant · 3 generations on · 1 of its ownK050889 Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K960880Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996 · cites it directly4descendants
- K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000 · 2 generations on3descendants
- K974642Combicath CatheterPlastimed Laboratoire Pharmaceutique · 1998 · cites it directly2descendants
- K112562Bal Cath Bronchial Aspirate Sampling CatheterKimberly-Clark · 2011 · cites it directly1descendant
- K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923487 | Bal Cath | Ballard Medical Products | 1993 | — |
| +1 | K960880 | Mill-Rose Blind Microbiology Brush | Mill-Rose Laboratory | 1996 | — |
| +2 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| +1 | K974642 | Combicath Catheter | Plastimed Laboratoire Pharmaceutique | 1998 | 6 |
| +1 | K112562 | Bal Cath Bronchial Aspirate Sampling Catheter | Kimberly-Clark | 2011 | — |
| +3 | K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KTR? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
4 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K960880 (Mill-Rose Laboratory, 1996) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KTR devicesKTR Tube, Aspirating, Bronchoscope, Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTR
FDA has decided no KTR device since 2007.
Median 510(k) review, days · KTR
Too few KTR 510(k)s in any year since 2007 to give a median.
Recalls per year · KTR
No recall names KTR since 2007.
Adverse event reports per year · KTR
1in 2021
MAUDE reports naming product code KTR, 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 | 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 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923487 · printed Nov 5, 2026
Cite this page
510(k) Report. “K923487: Bal Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K923487
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026