510(k) · Cleared

Cleared

Needle View CH Scope Kits

K141326510(k) TraditionalCleared Oct 8, 2014140-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

Biovision Technologies, LLC · HRX Arthroscope

Cleared on Oct 8, 2014 as substantially equivalent to K082293 (Biovision Technologies, LLC, 2008) and 4 other predicates after a 140-day review. Its family tree reaches back 6 generations to 1983. 3 later devices descend from it.

Decided: Oct 8, 2014
Review: 140 days
Class: Class II
Product code: HRX
Recalls: None
Predicates: 5

Its longest line of descent runs back 6 generations to K833587 (1983). 38 ancestors in all, the oldest K771218 (1978). 3 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 6 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
5 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
4 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
3 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
2 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
1 generation backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
This deviceK141326 Needle View CH Scope KitsBiovision Technologies, LLC · 2014
Descendant · cites it directly · 2 of its ownK181982 MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018
Descendant · 2 generations on · 1 of its ownK243020 MIDASVuIntravu, Inc. · 2024
Descendant · 3 generations on · 0 of its ownK252579 Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026

Most influential descendants

Showing 3 of 3 · See all

K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc. · 2018 · cites it directly2descendants
K243020MIDASVuIntravu, Inc. · 2024 · 2 generations on1descendant
K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc. · 2026 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K833587	Disposable Arthroscopy Blade	Dyonics, Inc.	1983	—
−5	K900070	Modified Uses of the Arthroscopic Surgical System	Dyonics, Inc.	1990	—
−4	K971253	Various Arthroscopes, Endoscopic Blades, Manual Instruments	Smith & Nephew, Inc.	1997	—
−3	K043395	Smith & Nephew Videoarthroscope	Smith & Nephew, Inc.	2005	—
−2	K072879	Innervue Diagnostic Scope System	Biomet Orthopedics, Inc.	2008	2
−1	K082293	Surgview Integrated Visualization System	Biovision Technologies, LLC	2008	—
0 (this device)	K141326	Needle View CH Scope Kits	Biovision Technologies, LLC	2014	—
+1	K181982	MIDAScope and Introducer Kit, and MIDASystem	Intravu, Inc.	2018	—
+2	K243020	MIDASVu	Intravu, Inc.	2024	—
+3	K252579	Orthoscan TAU MVP Mini C-Arm System	Ziehm-Orthoscan, Inc.	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1988	1	0
1990	1	0
1991	1	0
1992	2	0
1994	4	0
1995	3	0
1996	1	0
1998	1	0
1999	1	0
2000	3	0
2001	2	0
2002	3	0
2003	1	0
2004	1	0
2005	1	0
2006	2	0
2009	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K141326, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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
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What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K082293	Surgview Integrated Visualization System Summary page 4 …oscope Regulatory Class: II Product Codes(s): HRX, GCJ Predicate Devices BioVision SurgView™ Integrated Visualization System (K082293) Joimax THESSYS Multiscope (K051827) Hoogland Spine Products maxM…	Biovision Technologies, LLC	2008	—
*	K051827	Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys… Summary page 4 …HRX, GCJ Predicate Devices BioVision SurgView™ Integrated Visualization System (K082293) Joimax THESSYS Multiscope (K051827) Hoogland Spine Products maxMorespine Endoscope (K083552) Blazeje…	Joimax GmbH	2005	—
*	K083552	Maxmorespine Tom Stick Summary page 4 …tion System (K082293) Joimax THESSYS Multiscope (K051827) Hoogland Spine Products maxMorespine Endoscope (K083552) Blazejewski MEDI-Tech Spinal Foraminoscope (K082841) Richard Wol…	Hoogland Spine Products, GmbH	2009	—
*	K082841	Spinal Foraminoscope Summary page 4 …827) Hoogland Spine Products maxMorespine Endoscope (K083552) Blazejewski MEDI-Tech Spinal Foraminoscope (K082841) Richard Wolf Medical Instruments Corp. Endoscopic Spine System Set…	Blazejewski Medi-Tech GmbH	2009	—
*	K973405	Yeung Endoscopic Spine System Summary page 4 …Spinal Foraminoscope (K082841) Richard Wolf Medical Instruments Corp. Endoscopic Spine System Set (YESS) (K973405) Device Description Name of Device: NeedleView CH™ Scope Kit The NeedleView CH is a rigid Fiberoptic scope with a working cha…	Richard Wolf Medical Instruments Corp.	1998	—

Also cleared against K082293: 2 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181982	MIDAScope and Introducer Kit, and MIDASystem	Intravu, Inc.	2018	2

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 31 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
3 of the 38 ancestors have a recall of any class.
Of its descendants, K181982 (Intravu, Inc., 2018) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K082293.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

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	—

What is it indicated for?

This system is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K141326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141326: Needle View CH Scope Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141326

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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