510(k) · Cleared
ClearedMountable Endoscopic Knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.M. Surgical, Inc. · EMF Knife, Surgical
Cleared on Dec 30, 1998 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Dec 30, 1998
- Review
- 196 days
- Class
- Class I
- Product code
- EMF
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK982142 Mountable Endoscopic KnifeA.M. Surgical, Inc. · 1998
- Descendant · cites it directly · 9 of its ownK080133 Mountable Endoscopic BladeA.M. Surgical, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK181819 SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018
- Descendant · 3 generations on · 2 of its ownK223406 SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK222490 HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK252020 TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade…Hand Biomechanics Lab, Inc. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K080133Mountable Endoscopic BladeA.M. Surgical, Inc. · 2008 · cites it directly9descendants
- K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC · 2018 · 2 generations on6descendants
- K223406SmartRelease Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments · 2023 · 3 generations on2descendants
- K222490HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2022 · 3 generations on1descendant
- K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982142 | Mountable Endoscopic Knife | A.M. Surgical, Inc. | 1998 | — |
| +1 | K080133 | Mountable Endoscopic Blade | A.M. Surgical, Inc. | 2008 | — |
| +2 | K181819 | SMARTRELEASE Endoscopic Soft Tissue Release System | Microaire Surgical Instruments, LLC | 2018 | — |
| +3 | K223406 | SmartRelease Endoscopic Soft Tissue Release System | Microaire Surgical Instruments | 2023 | 1 |
| +3 | K222490 | HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2022 | — |
| +3 | K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly | Hand Biomechanics Lab, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 112 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?
- Of its descendants, K080133 (A.M. Surgical, Inc., 2008) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EMF devicesEMF Knife, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMF
1in 2008
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMF
5in 2025
MAUDE reports naming product code EMF, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 5 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982142 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982142: Mountable Endoscopic Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982142
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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