510(k) · Cleared
ClearedSuretek Medical Reprocessed Arthroscopic Blades and Burs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suretek Medical · NUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Cleared on May 10, 2006 as substantially equivalent to K953695 (Smith & Nephew Dyonics, Inc., 1995) and 3 other predicates after a 224-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- May 10, 2006
- Review
- 224 days
- Class
- Class II
- Product code
- NUJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K862807 (1986). 19 ancestors in all, the oldest K852143 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 4 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 3 generations backK971059 Universal Drive SystemLinvatec Corp. · 1997
- 2 generations backK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- 1 generation backK990524 E9000 SystemLinvatec Corp. · 1999
- This deviceK052695 Suretek Medical Reprocessed Arthroscopic Blades and BursSuretek Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −4 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −3 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| −2 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| −1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| 0 (this device) | K052695 | Suretek Medical Reprocessed Arthroscopic Blades and Burs | Suretek Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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 NUJ? 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 NUJ device
- #1 K220411 Reprocessed LigaSure Curved, Small Jaw, Open…score 8.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K953695 | Dyonics Disposable Arthroscopic BladesSummary page 1…A Classification Code:HRiX Regulation: 21 CFR888.1100 Manufacturer/Reprocessor 510(k) Predicate Dyonics (Smith & Nephew) K953695 Devices Stryker Corp K94 1333 Linvatec K990524… | 1995 |
| * | K941333 | SE5 Arthroscopy SytemSummary page 1…Manufacturer/Reprocessor 510(k) Predicate Dyonics (Smith & Nephew) K953695 Devices Stryker Corp K94 1333 Linvatec K990524 Xomed (Medtronic) K(010667… | 1994 |
| * | K990524 | E9000 SystemSummary page 1…dicate Dyonics (Smith & Nephew) K953695 Devices Stryker Corp K94 1333 Linvatec K990524 Xomed (Medtronic) K(010667 Vanguard Medical Concepts K(012346… | 1999 |
| Kept off the family tree | K010667 | FDA’s K010667 is Gambro Polyflux 24S, Gambro Polyflux 24R Our reading of the summary gave K010667, FDA’s number for Gambro Polyflux 24S, Gambro Polyflux 24R (Gambro Renal Products). Its FDA name has none of the distinctive words the summary uses for the device it names, “Xomed (Medtronic)”. Kept off the family tree. Summary page 1…es Stryker Corp K94 1333 Linvatec K990524 Xomed (Medtronic) K(010667 Vanguard Medical Concepts K(012346 MediSISS K(012667 Device… | 2001 |
| * | K012346 | Vanguard Reprocessed Arthroscopic BladesSummary page 1…Linvatec K990524 Xomed (Medtronic) K(010667 Vanguard Medical Concepts K(012346 MediSISS K(012667 Device Arthroscopic Shavers and Burs are powered instrume… | 2001 |
| Kept off the family tree | K012667 | FDA’s K012667 is Reprocessed Arthroscopic Shapers Our reading of the summary gave K012667, FDA’s number for Reprocessed Arthroscopic Shapers (Surgical Instruments Service and Savings, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MediSISS”. Kept off the family tree. Summary page 1…Xomed (Medtronic) K(010667 Vanguard Medical Concepts K(012346 MediSISS K(012667 Device Arthroscopic Shavers and Burs are powered instruments designed for cutting of soft tissue, Description car… | 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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 19 ancestors have a recall of any class.
- 10 other devices also cite its predicate K953695.
How does its category compare?
All NUJ devicesNUJ Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NUJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NUJ
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUJ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUJ
38in 2025
MAUDE reports naming product code NUJ, 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 | 4 |
| 2008 | 1 | — | 2 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 39 |
| 2013 | 2 | — | 0 | 161 |
| 2014 | 1 | — | 0 | 74 |
| 2015 | 2 | — | 0 | 25 |
| 2016 | 5 | 155 | 0 | 52 |
| 2017 | 3 | 49 | 0 | 51 |
| 2018 | 7 | 88 | 0 | 14 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 59 |
| 2021 | 0 | — | 0 | 47 |
| 2022 | 2 | — | 0 | 31 |
| 2023 | 1 | — | 3 | 27 |
| 2024 | 1 | — | 0 | 92 |
| 2025 | 0 | — | 11 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SureTek Reprocessed Arthroscopic Blades and Burs are intended for use during arthroscopic and endoscopic procedures for cutting and resection of soft tissue, cartilage and bone. Endoscopic sinus surgery is limited to small diameter instruments (2 to 3.5 mm).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052695: Suretek Medical Reprocessed Arthroscopic Blades and Burs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052695
Report an extraction error
Are you the manufacturer?
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