510(k) Report

510(k) · Cleared

Cleared

Mountable Endoscopic Blade

K080133510(k) TraditionalCleared Mar 13, 200855-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

A.M. Surgical, Inc. · EMF Knife, Surgical

Cleared on Mar 13, 2008 as substantially equivalent to K982142 (A.M. Surgical, Inc., 1998) after a 55-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.

Decided
Mar 13, 2008
Review
55 days
Class
Class I
Product code
EMF
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K982142 (1998). 9 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2020: 1 descendant cleared2021: 1 descendant cleared2010: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK982142 · Mountable Endoscopic Knife · A.M. Surgical, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K982142 · Mountable Endoscopic Knife · A.M. Surgical, Inc. · 19980
  1. Root · 1 generation backK982142 Mountable Endoscopic KnifeA.M. Surgical, Inc. · 1998
  2. This deviceK080133 Mountable Endoscopic BladeA.M. Surgical, Inc. · 2008
  3. Descendant · cites it directly · 6 of its ownK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
  4. Descendant · 2 generations on · 2 of its ownK223406 SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · Recalled
  5. Descendant · 2 generations on · 1 of its ownK222490 HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022
  6. Descendant · 2 generations on · 0 of its ownK252020 TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade…Hand Biomechanics Lab, Inc. · 2025
  7. Descendant · 3 generations on · 0 of its ownK252594 UltraGuideCTR® image guided soft tissue release systemSonex Health · 2025

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2010: 12018: 12020: 12021: 12022: 12023: 12024: 12025: 2
2010high 2 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 9 · See all
  • K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018 · cites it directly6descendants
  • K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · 2 generations on2descendants
  • K222490HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022 · 2 generations on1descendant
  • K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2025 · 2 generations on0descendants
  • K252594UltraGuideCTR® image guided soft tissue release systemSonex Health · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982142Mountable Endoscopic KnifeA.M. Surgical, Inc.1998—
0 (this device)K080133Mountable Endoscopic BladeA.M. Surgical, Inc.2008—
+1K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC2018—
+2K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20231
+2K222490HBL Blade AssemblyHand Biomechanics Lab, Inc.2022—
+2K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.2025—
+3K252594UltraGuideCTR® image guided soft tissue release systemSonex Health2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201810
202010
202110
202210
202310
202410
202520
FIG. 1 — Lineage of K080133, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 EMF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K982142Mountable Endoscopic Knife
Summary page 2
…terial composition, and design features of the Mountable Endoscopic Blade are substantially equivalent to previously cleared 510(k) Mountable Endoscopic Blade (K982142). The safety and effectiveness of Mountable Endoscopic Blade is adequately supported by the substantial equivalence inf…
A.M. Surgical, Inc.1998—

Also cleared against K982142: 1 other device →

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC20186
K211297SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments20210
K200559CarpXPavmed, Inc.20200
K102219Socorro Smi Tunnel Release DeviceSocorro Medical, Inc.20100

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.
  • Of its descendants, K181819 (Microaire Surgical Instruments, LLC, 2018) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K982142.

How does its category compare?

All EMF devices

EMF Knife, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · EMF

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMF

Too few EMF 510(k)s in any year since 2007 to give a median.

Recalls per year · EMF

5in 2017

2017: 5
2007high 5 (2017) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EMF

5in 2025

2007: 12009: 12010: 42011: 52012: 32014: 22015: 22016: 22017: 12019: 52020: 62021: 42022: 102023: 32024: 12025: 5
2007high 10 (2022) · low 0 (2008)2025

MAUDE reports naming product code EMF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—00
20090—01
20100—04
20110—05
20120—03
20130—00
20140—02
20150—02
20160—02
20170—51
20180—00
20190—05
20200—06
20210—04
20220—010
20230—03
20240—01
20250—05
20260—0—

What is it indicated for?

The Mountable Endoscopic Blade is indicated for use in minimally invasive ligament or fascia release.

* Carpal tunnel release for carpal tunnel syndrome

* Plantar fasciotomy for plantar fasciitis

* Lateral release of the knee for extensor mechanism malalignment

* Forearm fasciotomy for compartment syndrome

* Morton's neuroma for interdigital neuroma

* Gastrocnemius release for heel cord contracture (equinus)

Indications for use as stated in the FDA summary.

Also cleared against K982142

1 other device cites the same predicate.

  • K072684Mondeal Endoscopic Tissue Recession and Release SystemMondeal North America, Inc. · 2008

More from A.M. Surgical, Inc.

6 FDA decisions under this applicant name. See the company

  • K191771SECURE ScrewA.M. Surgical, Inc. · 2019
  • K191345Pegasus SystemA.M. Surgical, Inc. · 2019
  • K180087A.M. Surgical Intramedullary Fixation DeviceA.M. Surgical, Inc. · 2018
  • K042458A.M. Surgical CPF Distal Radial External Cross Pin Fixation SystemA.M. Surgical, Inc. · 2004
  • K982142Mountable Endoscopic KnifeA.M. Surgical, Inc. · 1998

Recent decisions in EMF

The EMF category page

  • K982142Mountable Endoscopic KnifeA.M. Surgical, Inc. · 1998
  • K890215Microsurgical ScarifierKinetic Medical Products · 1989
  • K890214Microsurgery Razor Blade HolderKinetic Medical Products · 1989
  • K890217Microsurgical KnivesKinetic Medical Products · 1989
  • K880094Van-Tec Endopyelotomy KnifeVan-Tec, Inc. · 1988

https://510kreport.com/device/K080133 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080133: Mountable Endoscopic Blade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080133

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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