510(k) · Cleared
ClearedMedline Renewal Reprocessed Gyrus-Diego Sinus Application Blades
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Renewal · NLY Microdebrider, Ent, High Speed, Single Use, Reprocessed
Cleared on Dec 19, 2014 as substantially equivalent to K020594 (Gyrus Ent LLC, 2002) after a 147-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Dec 19, 2014
- Review
- 147 days
- Class
- Class I
- Product code
- NLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020594 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK020594 Diego Powered Dissector and Drill SystemGyrus Ent LLC · 2002
- This deviceK142022 Medline Renewal Reprocessed Gyrus-Diego Sinus Application BladesMedline Renewal · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020594 | Diego Powered Dissector and Drill System | Gyrus Ent LLC | 2002 | — |
| 0 (this device) | K142022 | Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades | Medline Renewal | 2014 | — |
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 NLY? 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? (1)
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 |
|---|---|---|---|
| * | K020594 | Diego Powered Dissector and Drill SystemSummary page 5…haver, reprocessed § 874.4140 - ear, nose, and throat bur Classification Class I, nonexempt Product Code NLY Predicate K020594 Sinus Application Blades of the Diego Powered Dissector and Device Drill System manufactured by OLYMPUS/Gyrus ACMI.… | 2002 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K020594.
How does its category compare?
All NLY devicesNLY Microdebrider, Ent, High Speed, Single Use, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NLY
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · NLY
Too few NLY 510(k)s in any year since 2007 to give a median.
Recalls per year · NLY
No recall names NLY since 2007.
Adverse event reports per year · NLY
1in 2007
MAUDE reports naming product code NLY, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 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 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Medline ReNewal Reprocessed Gyrus-Diego Sinus Application Blades are designed for use in limited sinus applications involving soft tissue and thin bone such as lamina papyracea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142022: Medline Renewal Reprocessed Gyrus-Diego Sinus Application Blades.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142022
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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