510(k) · Cleared
ClearedMill-Rose Blind Microbiology Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mill-Rose Laboratory · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Apr 29, 1996 as substantially equivalent to K820771 (Mill-Rose Laboratory, 1982) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1982. 4 later devices descend from it.
- Decided
- Apr 29, 1996
- Review
- 56 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820771 (1982). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK820771 Microbiology Specimen BrushMill-Rose Laboratory · 1982
- This deviceK960880 Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996
- Descendant · cites it directly · 3 of its ownK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- Descendant · 2 generations on · 1 of its ownK050889 Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005
- Descendant · 2 generations on · 1 of its ownK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · 3 generations on · 0 of its ownK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
Most influential descendants
Showing 4 of 4 · See all- K993614Fas Endoluminal BrushFas Medical, Ltd. · 2000 · cites it directly3descendants
- K050889Fibrin Analysis System Endoluminal BrushCrs Medical Diagnostics, Inc. · 2005 · 2 generations on1descendant
- K012641Fas Endoluminal BrushFas Medical, Ltd. · 2001 · 2 generations on1descendant
- K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820771 | Microbiology Specimen Brush | Mill-Rose Laboratory | 1982 | — |
| 0 (this device) | K960880 | Mill-Rose Blind Microbiology Brush | Mill-Rose Laboratory | 1996 | — |
| +1 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| +2 | K050889 | Fibrin Analysis System Endoluminal Brush | Crs Medical Diagnostics, Inc. | 2005 | — |
| +2 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +3 | K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K820771 | Microbiology Specimen BrushSummary page 1…sification Name: Not Known 5.) Common Name: Blind Protected Specimen Brush 6.) Proprietary Name: Mill-Rose Blind Microbiology Brush 7.) Substantially Equivalent Device: K820771 - Mill-Rose Laboratories, Inc., Microbiology Brush K923487 - Ballard Medical Products, BAL Cath® 8.) Description of Subject Dev… | 1982 |
| * | K923487 | Bal CathSummary page 1…Specimen Brush 6.) Proprietary Name: Mill-Rose Blind Microbiology Brush 7.) Substantially Equivalent Device: K820771 - Mill-Rose Laboratories, Inc., Microbiology Brush K923487 - Ballard Medical Products, BAL Cath® 8.) Description of Subject Device: The subject device is sterile and consists of a flexibl… | 1993 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993614 | Fas Endoluminal Brush | 2000 | 3 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K993614 (Fas Medical, Ltd., 2000) has gone furthest, with 3 descendants of its own.
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 device is intended to allow blind, non-directed, protected specimen brush sampling of the lower respiratory tract secretions or to perform surveillance cultures or to diagnose pneumonia in patients receiving mechanical ventilation.
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/K960880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960880: Mill-Rose Blind Microbiology Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960880
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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