510(k) Report

510(k) · Cleared

Cleared

Mitaka Uniarm

K090792510(k) TraditionalCleared Jul 6, 2009104-day reviewClass II21 CFR 876.1500

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

Mitaka Kohki Co., Ltd. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jul 6, 2009 as substantially equivalent to K984355 (Mitaka USA, Inc., 1999) and 3 other predicates after a 104-day review. Its family tree reaches back 3 generations to 1995.

Decided
Jul 6, 2009
Review
104 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K951854 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 2 other ancestorsK951854 · Leonard Arm - Support Arm - Endoscopic Accessory · Leonard Medical, Inc. · 1995K973543 · Kronner Low Profile Scope Holder · Kronner Prototypes, Inc. · 1998K000663 · Kronner Low Profile Scope Holder · Kronner Prototypes, Inc. · 20001995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors K000663 · Kronner Low Profile Scope Holder · Kronner Prototypes, Inc. · 2000K973543 · Kronner Low Profile Scope Holder · Kronner Prototypes, Inc. · 1998K951854 · Leonard Arm - Support Arm - Endoscopic Accessory · Leonard Medical, Inc. · 19950
  1. Root · 3 generations backK951854 Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc. · 1995
  2. 2 generations backK973543 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 1998
  3. 1 generation backK000663 Kronner Low Profile Scope HolderKronner Prototypes, Inc. · 2000
  4. This deviceK090792 Mitaka UniarmMitaka Kohki Co., Ltd. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K951854Leonard Arm - Support Arm - Endoscopic AccessoryLeonard Medical, Inc.1995—
−2K973543Kronner Low Profile Scope HolderKronner Prototypes, Inc.1998—
−1K000663Kronner Low Profile Scope HolderKronner Prototypes, Inc.2000—
0 (this device)K090792Mitaka UniarmMitaka Kohki Co., Ltd.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
FIG. 1 — Lineage of K090792, 1995–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 GCJ? 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 GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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
*K984355Point Setter
Summary page 1
…itional Product Classification KOG, & GCJ 1. The legally marketed devices to which Mitaka Kohki is claiming equivalence: Mitaka Point Setter - K984355 Endoscope holder, K991989 Neuro Dia and clinical use Kroner - Wingman Scope Holder - K000663 General Surgery, K9…
Mitaka USA, Inc.19991
*K991989Mitaka Point Setter
Summary page 1
…tion KOG, & GCJ 1. The legally marketed devices to which Mitaka Kohki is claiming equivalence: Mitaka Point Setter - K984355 Endoscope holder, K991989 Neuro Dia and clinical use Kroner - Wingman Scope Holder - K000663 General Surgery, K973543 General Surgery 2.…
Mitaka USA, Inc.1999—
*K000663Kronner Low Profile Scope Holder
Summary page 1
…aiming equivalence: Mitaka Point Setter - K984355 Endoscope holder, K991989 Neuro Dia and clinical use Kroner - Wingman Scope Holder - K000663 General Surgery, K973543 General Surgery 2. Description of the Mitaka UniARM: Summary: the Mitaka UniARM-device…
Kronner Prototypes, Inc.2000—
*K973543Kronner Low Profile Scope Holder
Summary page 1
…Mitaka Point Setter - K984355 Endoscope holder, K991989 Neuro Dia and clinical use Kroner - Wingman Scope Holder - K000663 General Surgery, K973543 General Surgery 2. Description of the Mitaka UniARM: Summary: the Mitaka UniARM-device is for use in holding med…
Kronner Prototypes, Inc.1998—

What descends from it?

No later submission names this one as a predicate yet.

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 14 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • 1 of the 5 ancestors has a recall of any class.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.

Indications for use as stated in the FDA summary.

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K090792 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090792: Mitaka Uniarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090792

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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