510(k) · Cleared
ClearedProline Fast Pass Arthoscopic Needle Passer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acufex Microsurgical, Inc. · HRX Arthroscope
Cleared on Jun 21, 1996 after a 38-day review; its predicate, P810028, is listed below. 1 later device descends from it.
- Decided
- Jun 21, 1996
- Review
- 38 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
1 ancestor in all. 1 later device descends from it, 1 citing it directly.
- This deviceK961853 Proline Fast Pass Arthoscopic Needle PasserAcufex Microsurgical, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK970416 Acufex Double Armed Suture NeedleSmith & Nephew Endoscopy, Inc. · 1997
Most influential descendants
Showing 1 of 1 · See all- K970416Acufex Double Armed Suture NeedleSmith & Nephew Endoscopy, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961853 | Proline Fast Pass Arthoscopic Needle Passer | Acufex Microsurgical, Inc. | 1996 | — |
| +1 | K970416 | Acufex Double Armed Suture Needle | Smith & Nephew Endoscopy, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 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? (4)
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 |
|---|---|---|---|
| Kept off the family tree | K830509 | FDA’s K830509 is Emergency Tracheostomy & Cricothyroido- Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1983 |
| Kept off the family tree | K850378 | FDA’s K850378 is LDH Reagent for Demand Analyzer Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1985 |
| * | P810028 | Deklene (TM) FDA lists this PMA only through its supplements; the earliest we hold is P810028/S001 (Jun 22, 1983). Summary page 1…ic Suture Passer Ti-Cron Sutures (Davis & Geck., N83-509) Linvatec, Inc. (Largo, F1.) Surgical Specialties Braided Polyester Suture (N85-378) Deknatel Silky II Polydek (P810028) 051 Device The Fast Pass Suture Punch System is indicated for the placement of sutures in Indications Rotator… | |
| * | — | Shutt Arthroscopic Suture Passer Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970416 | Acufex Double Armed Suture Needle | 1997 | 0 |
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?
- Of its descendants, K970416 (Smith & Nephew Endoscopy, Inc., 1997) has gone furthest, with 0 descendants of its own.
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 Fast Pass Suture Punch System is indicated for the placement of sutures in Rotator Cuff and Bankart repair procedures.
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/K961853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961853: Proline Fast Pass Arthoscopic Needle Passer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961853
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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