510(k) · Cleared

Cleared

Shaver Blade Set

K940075510(k) TraditionalCleared Apr 15, 199499-day reviewClass II21 CFR 888.1100

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

Cleared on Apr 15, 1994 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 8 later devices descend from it.

Decided: Apr 15, 1994
Review: 99 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 0

8 later devices descend from it, 2 citing it directly.

This deviceK940075 Shaver Blade SetArthrex, Inc. · 1994
Descendant · cites it directly · 6 of its ownK041824 X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · Recalled
Descendant · 2 generations on · 2 of its ownK050580 Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005
Descendant · 3 generations on · 1 of its ownK051326 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · Recalled
Descendant · 4 generations on · 0 of its ownK171794 Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK131191 4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM…Depuy Mitek, A Johnson & Johnson Company · 2013

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005high 3 (2005) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all

K041824X-Treme Arthroscopic Pump and Shaver SystemFuture Medical Systems, SA · 2005 · cites it directly6descendants
K050580Smith & Nephew Intelijet Fluid Management SystemsSmith & Nephew Endoscopy, Inc. · 2005 · 2 generations on2descendants
K051326Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2005 · 3 generations on1descendant
K171794Smith & Nephew 25 Fluid Management SystemSmith & Nephew, Inc. · 2017 · 4 generations on0descendants
K1311914MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado Bur Plus…Depuy Mitek, A Johnson & Johnson Company · 2013 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940075	Shaver Blade Set	Arthrex, Inc.	1994	—
+1	K041824	X-Treme Arthroscopic Pump and Shaver System	Future Medical Systems, SA	2005	2
+2	K050580	Smith & Nephew Intelijet Fluid Management Systems	Smith & Nephew Endoscopy, Inc.	2005	—
+3	K051326	Smith & Nephew 25 Fluid Management System	Smith & Nephew, Inc.	2005	6
+4	K171794	Smith & Nephew 25 Fluid Management System	Smith & Nephew, Inc.	2017	—
+2	K131191	4MM & 5MM Full Radius Blade Plus, 4MM & 5MM Barrel Bur Plus/4MM Barrel Tornado…	Depuy Mitek, A Johnson & Johnson Company	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2006	1	0
2011	1	0
2013	2	0
2017	1	0

FIG. 1 — Lineage of K940075, 1994–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K041824	X-Treme Arthroscopic Pump and Shaver System	Future Medical Systems, SA	2005	6
K113028	Medisiss Reprocessed Arthroscopic Shavers and Burs	Medisiss	2011	0

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, K041824 (Future Medical Systems, SA, 2005) has gone furthest, with 6 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007high 2,427 (2024) · low 421 (2007)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	—

https://510kreport.com/device/K940075 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940075: Shaver Blade Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940075

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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