510(k) · Cleared
ClearedEssential Shaver System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Richards, Inc. · EQJ Bur, Ear, Nose And Throat
Cleared on Jul 28, 1995 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Jul 28, 1995
- Review
- 25 days
- Class
- Class I
- Product code
- EQJ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 4 citing it directly.
- This deviceK953096 Essential Shaver SystemSmith & Nephew Richards, Inc. · 1995
- Descendant · cites it directly · 11 of its ownK973195 Total Performance System ShaverStryker Endoscopy · 1997
- Descendant · 2 generations on · 4 of its ownK071859 Stryker Crossfire SystemStryker Endoscopy · 2007 · Recalled
- Descendant · 3 generations on · 2 of its ownK162770 Relign SystemRelign Corporation · 2017
- Descendant · 2 generations on · 2 of its ownK061134 Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006
- Descendant · 4 generations on · 1 of its ownK233493 Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera…Relign Corporation · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K973195Total Performance System ShaverStryker Endoscopy · 1997 · cites it directly11descendants
- K071859Stryker Crossfire SystemStryker Endoscopy · 2007 · 2 generations on4descendants
- K162770Relign SystemRelign Corporation · 2017 · 3 generations on2descendants
- K061134Eberle Shaver System C2 and Shaver BladesEfs Eberle Feinwerktechnische Systeme · 2006 · 2 generations on2descendants
- K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953096 | Essential Shaver System | Smith & Nephew Richards, Inc. | 1995 | — |
| +1 | K973195 | Total Performance System Shaver | Stryker Endoscopy | 1997 | — |
| +2 | K071859 | Stryker Crossfire System | Stryker Endoscopy | 2007 | 2 |
| +3 | K162770 | Relign System | Relign Corporation | 2017 | — |
| +2 | K061134 | Eberle Shaver System C2 and Shaver Blades | Efs Eberle Feinwerktechnische Systeme | 2006 | — |
| +4 | K233493 | Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver… | Relign Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EQJ? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 154 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, K973195 (Stryker Endoscopy, 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All EQJ devicesEQJ Bur, Ear, Nose And Throat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EQJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · EQJ
Too few EQJ 510(k)s in any year since 2007 to give a median.
Recalls per year · EQJ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EQJ
435in 2025
MAUDE reports naming product code EQJ, 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 | 21 |
| 2008 | 0 | — | 0 | 21 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 30 |
| 2011 | 0 | — | 0 | 65 |
| 2012 | 0 | — | 0 | 84 |
| 2013 | 0 | — | 0 | 76 |
| 2014 | 0 | — | 0 | 95 |
| 2015 | 0 | — | 0 | 93 |
| 2016 | 0 | — | 0 | 95 |
| 2017 | 1 | — | 0 | 118 |
| 2018 | 0 | — | 0 | 204 |
| 2019 | 0 | — | 0 | 129 |
| 2020 | 0 | — | 0 | 100 |
| 2021 | 0 | — | 1 | 131 |
| 2022 | 0 | — | 0 | 229 |
| 2023 | 0 | — | 0 | 261 |
| 2024 | 0 | — | 0 | 368 |
| 2025 | 0 | — | 0 | 435 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K953096: Essential Shaver System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953096
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026