510(k) · Cleared
ClearedSMARTRELEASE Endoscopic Soft Tissue Release System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments, LLC · HRX Arthroscope
Cleared on Nov 6, 2018 as substantially equivalent to K080133 (A.M. Surgical, Inc., 2008) and 2 other predicates after a 120-day review. Its family tree reaches back 5 generations to 1984. 6 later devices descend from it.
- Decided
- Nov 6, 2018
- Review
- 120 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K844002 (1984). 25 ancestors in all, the oldest K771218 (1978). 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 4 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 3 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 2 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 1 generation backK032119 Paragon Medical Surgical Instrument Delivery System VariousParagon Medical, Inc. · 2003
- This deviceK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
- Descendant · cites it directly · 2 of its ownK223406 SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · Recalled
- Descendant · cites it directly · 1 of its ownK222490 HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252020 TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade…Hand Biomechanics Lab, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK252594 UltraGuideCTR® image guided soft tissue release systemSonex Health · 2025
- Descendant · 2 generations on · 0 of its ownK242417 VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · cites it directly2descendants
- K222490HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022 · cites it directly1descendant
- K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2025 · cites it directly0descendants
- K252594UltraGuideCTR® image guided soft tissue release systemSonex Health · 2025 · 2 generations on0descendants
- K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −4 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −3 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −2 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −1 | K032119 | Paragon Medical Surgical Instrument Delivery System Various | Paragon Medical, Inc. | 2003 | — |
| 0 (this device) | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | 2018 | — |
| +1 | K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023 | 1 |
| +1 | K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022 | — |
| +1 | K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025 | — |
| +2 | K252594 | UltraGuideCTR® image guided soft tissue release system | Sonex Health | 2025 | — |
| +2 | K242417 | VECTR – Video Endoscopic Carpal Tunnel Release System | Rafael Medical Devices, LLC | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080133 | Mountable Endoscopic BladeSummary page 4…EMF Predicate Devices Deployment Handle and Blade Assembly Primary Predicate – A.M. Surgical Mountable Endoscopic Blade - K080133 (Class I), A.M. Surgical STRATOS® Endoscopic 1… | 2008 |
| * | K080560 | Henke Sass Wolf of America ArthroscopeSummary page 5…- K881703 (Class II) Carpal Tunnel Release. Arthroscope Primary Predicate - Henke Sass Wolfe Arthroscope: K080560 (Class II); Sterilization Tray Primary Predicate - Paragon Medical Inc. Surgical Instru… | 2008 |
| * | K032119 | Paragon Medical Surgical Instrument Delivery System VariousSummary page 5…throscope: K080560 (Class II); Sterilization Tray Primary Predicate - Paragon Medical Inc. Surgical Instrument Delivery System: K032119 (Class II); Device Description MicroAire’s SMARTRELEASE® Endoscopic Soft Tissue Relea… | 2003 |
| * | — | A.M. Surgical STRATOS® Endoscopic Release System – Carpal and Cubital Tunnel Release Named without a submission number | |
| † | K881703 | 3M Carpal Tunnel | 1988 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 34 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- None of the 25 ancestors has a recall.
- Of its descendants, K223406 (Microaire Surgical Instruments, 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K080133.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 MicroAire SMARTRELEASE® 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181819: SMARTRELEASE Endoscopic Soft Tissue Release System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181819
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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