510(k) · Cleared
ClearedTunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hand Biomechanics Lab, Inc. · HRX Arthroscope
Cleared on Oct 15, 2025 as substantially equivalent to K181819 (Microaire Surgical Instruments, LLC, 2018) and 1 other predicate after a 107-day review. Its family tree reaches back 7 generations to 1984.
- Decided
- Oct 15, 2025
- Review
- 107 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K844002 (1984). 27 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 7 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 6 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 5 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 4 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 3 generations backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- 2 generations backK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
- 1 generation backK222490 HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022
- This deviceK252020 TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade…Hand Biomechanics Lab, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −6 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −5 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −4 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −3 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| −2 | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | 2018 | — |
| −1 | K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022 | — |
| 0 (this device) | K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release SystemSummary page 5…T) - Class I – Manual Surgical Instruments 21 CFR 878.4800 (EMF) Predicate Devices: - Primary Predicate: MicroAire® SmartRelease® Endoscopic Soft Tissue Release System (K181819) - Additional Predicate: HBL Blade Assembly, Model CTR-455 (K222490) Device Description: Hand Biomechanics Lab’s TunnelVision En… | 2018 |
| * | K222490 | HBL Blade AssemblySummary page 5…edicate Devices: - Primary Predicate: MicroAire® SmartRelease® Endoscopic Soft Tissue Release System (K181819) - Additional Predicate: HBL Blade Assembly, Model CTR-455 (K222490) Device Description: Hand Biomechanics Lab’s TunnelVision Endoscopic Soft Tissue Release System is a surgical system designed fo… | 2022 |
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 41 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- None of the 27 ancestors has a recall.
- 3 other devices also cite its predicate K181819.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:
Carpal tunnel release in the wrist
Cubital tunnel release in the elbow
The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release:
Carpal tunnel release in the wrist
Cubital tunnel release in the elbow
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/K252020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252020
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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