510(k) · Cleared
ClearedExmoor Suction Clearance Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exmoor Plastics, Ltd. · LRC Instrument, Ent Manual Surgical
Cleared on Mar 5, 1999 as substantially equivalent to K973587 (Exmoor Plastics, Ltd., 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 5, 1999
- Review
- 28 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973587 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK973587 Exmoor Tympanocentesis Kit (TK/1)Exmoor Plastics, Ltd. · 1998
- This deviceK990366 Exmoor Suction Clearance KitExmoor Plastics, Ltd. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973587 | Exmoor Tympanocentesis Kit (TK/1) | Exmoor Plastics, Ltd. | 1998 | — |
| 0 (this device) | K990366 | Exmoor Suction Clearance Kit | Exmoor Plastics, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 LRC? 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 LRC device
- #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K973587 | Exmoor Tympanocentesis Kit (TK/1)Summary page 1…edicate Devices: Exmoor Suction Clearance Kit Ear Suction Clearance Kit Surgical Instrument Kit, Disposable 79 KDD Richards Ear Examkit, Exmoor Tympanocentesis Kit (510K 973587), Exmoor Myringotomy Kit (510K 980828) Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suc… | 1998 |
| * | K980828 | Exmoor Myringotomy KitSummary page 1…ance Kit Ear Suction Clearance Kit Surgical Instrument Kit, Disposable 79 KDD Richards Ear Examkit, Exmoor Tympanocentesis Kit (510K 973587), Exmoor Myringotomy Kit (510K 980828) Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curett… | 1998 |
| * | — | Richards Ear Examkit Named without a submission number |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LRC
131in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRC
44in 2025
MAUDE reports naming product code LRC, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 2 | — | 0 | 11 |
| 2011 | 6 | 106 | 0 | 14 |
| 2012 | 7 | 50 | 0 | 48 |
| 2013 | 7 | 104 | 0 | 53 |
| 2014 | 3 | 29 | 0 | 53 |
| 2015 | 6 | 105 | 0 | 41 |
| 2016 | 3 | 100 | 0 | 39 |
| 2017 | 2 | — | 0 | 32 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 4 | 131 | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 25 |
| 2023 | 1 | — | 1 | 14 |
| 2024 | 0 | — | 1 | 51 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The need to clear and clean the external ear canal.
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/K990366 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990366: Exmoor Suction Clearance Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990366
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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