510(k) · Cleared
ClearedMill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit
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 Oct 30, 1998 as substantially equivalent to K914181 (Mill-Rose Laboratory, 1991) and 1 other predicate after a 52-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Oct 30, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852607 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK852607 Monject Sterile 20CC SyringesSherwood Medical Co. · 1985
- This deviceK983124 Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna)…Mill-Rose Laboratory · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852607 | Monject Sterile 20CC Syringes | Sherwood Medical Co. | 1985 | — |
| 0 (this device) | K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology… | Mill-Rose Laboratory | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 |
|---|---|---|---|
| * | K914181 | Wang/Mill-Rose Transbronchial Aspiration NeedleSummary page 1…be intended. The following chart lists the components, their 510(k) status, and classification. Components 510(k) Status Classification (20cc) "MRL transbronchial K914181 21 C.F.R. § 874.4680 aspiration needle (TBAN) Bronchoscope (flexible or of choice” rigid) and accessories, Class i MW-100 lock… | 1991 |
| * | K852607 | Monject Sterile 20CC SyringesSummary page 1…RL transbronchial K914181 21 C.F.R. § 874.4680 aspiration needle (TBAN) Bronchoscope (flexible or of choice” rigid) and accessories, Class i MW-100 lockable syringe | K852607 21 C.F.R. § 880.5860 Piston syringe, Class Il 95% EtOH fixative (60cc) Exempt from premarket notification 21 C.F.R. § 864.401… | 1985 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 8 other devices also cite its predicate K914181.
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 Transbronchial Needle Aspiration Cytology Procedural Kit is intended to retrieve and handle specimens and to prepare them for proper cytopathic examination.
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/K983124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983124: Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983124
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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