510(k) Report

510(k) · Cleared

Cleared

Sony IP Converter NU-IP40S

K161122510(k) TraditionalCleared Jun 8, 201648-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

Sony Electronics, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 8, 2016 as substantially equivalent to K122167 (Barco N.V., 2013) and 2 other predicates after a 48-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.

Decided
Jun 8, 2016
Review
48 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
3

Its longest line of descent runs back 9 generations to K931783 (1993). 40 ancestors in all, the oldest K801623 (1980). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2005: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1998: 2 other ancestors1997: 4 other ancestors1996: 5 other ancestors1995: 8 other ancestors1994: 1 other ancestor1993: 1 other ancestor1991: 3 other ancestors1992: 1 other ancestor1988: 1 other ancestor1980: 1 other ancestor2020: 1 descendant clearedK931783 · Aesop (Automated Endoscopic System for Optimal Pos · Computer Motion, Inc. · 1993K960655 · Aesop System and Accessories · Computer Motion, Inc. · 1996×2: 2 generations cleared close together, K973700 (1998), K980787 (1998) ×2: 2 generations cleared close together, K990691 (1999), K991444 (1999) K022393 · Merdoc System · Stryker Endoscopy · 2003K033132 · Stryker Switchpoint Infinity · Stryker Communications Corp. · 2004 · recalledK070556 · Brainsuite Net · Brainlab AG · 200719801990200020102020
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 5 generations between
  3. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  4. 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
  5. 1 generation backK070556 Brainsuite NetBrainlab AG · 2007
  6. This deviceK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016
  7. Descendant · cites it directly · 0 of its ownK191678 IP ConverterSony Electronics, Inc. · 2020
Show all 9 generations
  1. Root · 9 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
  2. 8 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
  3. 7 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
  4. 6 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
  5. 5 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
  6. 4 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
  7. 3 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
  8. 2 generations backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
  9. 1 generation backK070556 Brainsuite NetBrainlab AG · 2007
  10. This deviceK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K191678IP ConverterSony Electronics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K931783Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc.1993—
−8K960655Aesop System and AccessoriesComputer Motion, Inc.1996—
−7K973700Hermes Operating Room Control CenterComputer Motion, Inc.1998—
−6K980787Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc.1998—
−5K990691Hermes Operating Room Control CenterComputer Motion, Inc.1999—
−4K991444Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready).Computer Motion, Inc.1999—
−3K022393Merdoc SystemStryker Endoscopy2003—
−2K033132Stryker Switchpoint InfinityStryker Communications Corp.200411
−1K070556Brainsuite NetBrainlab AG2007—
0 (this device)K161122Sony IP Converter NU-IP40SSony Electronics, Inc.2016—
+1K191678IP ConverterSony Electronics, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198810
199130
199210
199310
199410
199580
199650
199740
199820
200110
200210
200510
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K161122, 1993–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (3)

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
*K122167Nexxis or
Summary page 4
…NU-IP40S 5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122167 K070556 K033132…
Barco N.V.2013—
*K070556Brainsuite Net
Summary page 4
…5.3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122167 K070556 K033132 Stryker Communications…
Brainlab AG2007—
*K033132Stryker Switchpoint Infinity
Summary page 4
…e legally marketed devices to which substantial equivalence is being claimed are: 510(k) Number: K122167 K070556 K033132 Stryker Communications Applicant:…
Stryker Communications Corp.200411

Also cleared against K122167: 2 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K191678IP ConverterSony Electronics, Inc.20200

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 23 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 40 ancestors has a recall of any class.
  • Of its descendants, K191678 (Sony Electronics, Inc., 2020) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K122167.

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. 2016, 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 Sony IP Converter’s (IPC) intended use is to distribute patient images acquired from modalities within a hospital or clinical environment in almost real-time.

The IPC can send audio visual signals and medical images to various commercially available products such as displays or recording devices commonly used in a medical procedure room or operating room.

The IPC allows for the switching of images easily among devices connected to an IPC in the operating room or throughout a healthcare campus.

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

Cite this page

510(k) Report. “K161122: Sony IP Converter NU-IP40S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161122

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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