510(k) · Cleared
ClearedTuta Healthcare Arthroscopy Flushing Set, Model 80.601
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuta Healthcare Pty Limited · HRX Arthroscope
Cleared on Feb 12, 2002 as substantially equivalent to K883300 (Edwards Orthopaedics Div., Baxter Healthcare Corp., 1988) after a 33-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Feb 12, 2002
- Review
- 33 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883300 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883300 Irrigation SetEdwards Orthopaedics Div., Baxter Healthcare Corp. · 1988
- This deviceK020083 Tuta Healthcare Arthroscopy Flushing Set, Model 80.601Tuta Healthcare Pty Limited · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883300 | Irrigation Set | Edwards Orthopaedics Div., Baxter Healthcare Corp. | 1988 | — |
| 0 (this device) | K020083 | Tuta Healthcare Arthroscopy Flushing Set, Model 80.601 | Tuta Healthcare Pty Limited | 2002 | — |
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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 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? (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 |
|---|---|---|---|
| * | K883300 | Irrigation SetSummary page 1…e: Tuta Healthcare Arthroscopy Flushing Set 80.601 Classification Name: Arthroscope Accessory (per 21CFR 888.1100) 3. Legally Marketed Equivalent Device Irrigation Set (K883300) — Edwards Orthopedic Division, Baxter Healthcare The. Arthroscopy Flushing set in the submission is substantially equivalent to… | 1988 |
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.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Tuta Healthcare Pty. Limited Arthroscopy Flushing set (80.601) is a gravity system for fluid-management during arthroscopic procedures. During these procedures, the fluid is used to (1) distend the site, enabling good visibility and (2) flush it continuously to clear debris (loose bodies or cartilage fragments away).
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/K020083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020083: Tuta Healthcare Arthroscopy Flushing Set, Model 80.601.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020083
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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