510(k) · Cleared
ClearedMill-Rose Laryngoscopic Injection Needle
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 Jul 29, 1996 as substantially equivalent to K914181 (Mill-Rose Laboratory, 1991) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Jul 29, 1996
- Review
- 14 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820973 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- This deviceK962736 Mill-Rose Laryngoscopic Injection NeedleMill-Rose Laboratory · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| 0 (this device) | K962736 | Mill-Rose Laryngoscopic Injection Needle | Mill-Rose Laboratory | 1996 | — |
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…scope and Accessory 5.) Common Name: Laryngoscopic Injection Needle 6.) Proprietary Name: Mill-Rose Laryngoscopic Injection Needle 7.) Substantially Equivalent Devices: K914181: Wang/Mill-Rose Transbronchial Aspiration Needle K820973: Endoscopic Injection Needle 8.) Description of Subject Device: The de… | 1991 |
| * | K820973 | Endoscopic Injection NeedleSummary page 1…ion Needle 6.) Proprietary Name: Mill-Rose Laryngoscopic Injection Needle 7.) Substantially Equivalent Devices: K914181: Wang/Mill-Rose Transbronchial Aspiration Needle K820973: Endoscopic Injection Needle 8.) Description of Subject Device: The device consists of an outer catheter and an inner catheter… | 1982 |
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 device is intended to be used through a laryngoscope for the therapeutic injection the larynx for various laryngeal disorders such as paralysis, tissue deficiency, contact ulcers and spasmodic dysphonia.
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/K962736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962736: Mill-Rose Laryngoscopic Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962736
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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