510(k) · Cleared
ClearedHD-550 Video Endoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoscape Medical Corp. · NWB Endoscope, Accessories, Narrow Band Spectrum
Cleared on Apr 1, 2022 as substantially equivalent to K173921 (Sonoscape Medical Corp., 2018) after a 284-day review. Its family tree reaches back 9 generations to 1993. 3 of the 31 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 1, 2022
- Review
- 284 days
- Class
- Class II
- Product code
- NWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931154 (1993). 29 ancestors in all, the oldest K843084 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 31 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 5 generations between
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK173921 HD-500 Video Endoscope SystemSonoscape Medical Corp. · 2018
- This deviceK211882 HD-550 Video Endoscope SystemSonoscape Medical Corp. · 2022
- Descendant · cites it directly · 0 of its ownK222020 HD-550 Video Endoscope SystemSonoscape Medical Corp. · 2022
Show all 9 generations
- Root · 9 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 8 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 7 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 6 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 5 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 4 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 3 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 2 generations backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- 1 generation backK173921 HD-500 Video Endoscope SystemSonoscape Medical Corp. · 2018
- This deviceK211882 HD-550 Video Endoscope SystemSonoscape Medical Corp. · 2022
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K222020HD-550 Video Endoscope SystemSonoscape Medical Corp. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −8 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −7 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −6 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −5 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −4 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −3 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −2 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| −1 | K173921 | HD-500 Video Endoscope System | Sonoscape Medical Corp. | 2018 | — |
| 0 (this device) | K211882 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | 2022 | — |
| +1 | K222020 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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.
3 devices in this family have a Class I recall. 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 NWB device
- #1 K222020 HD-550 Video Endoscope Systemscore 6.7 · 10 generations · no Class I recall
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K173921 | HD-500 Video Endoscope SystemSummary page 6…Series Light Source provides illumination for endoscopic diagnosis, treatment and video observation. 6. Identification of Predicate Device 510(k) Number: K173921 Product Name: HD-500 Video Endoscope System. Primary Components and Component Models: EG-500 Series Video Gastros… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222020 | HD-550 Video Endoscope System | 2022 | 0 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 3 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 5 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 16 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K222020 (Sonoscape Medical Corp., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NWB devicesNWB Endoscope, Accessories, Narrow Band Spectrum: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NWB
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NWB
Too few NWB 510(k)s in any year since 2007 to give a median.
Recalls per year · NWB
5in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NWB
2,847in 2025
MAUDE reports naming product code NWB, 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 | 2 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 22 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 17 |
| 2018 | 1 | — | 3 | 4 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 823 |
| 2021 | 0 | — | 0 | 1,453 |
| 2022 | 2 | — | 0 | 1,828 |
| 2023 | 0 | — | 5 (2) | 2,180 |
| 2024 | 0 | — | 0 | 2,648 |
| 2025 | 0 | — | 0 | 2,847 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HD-550 Video Endoscope System The HD-550 video endoscope system, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract. EG-550 Series Video Gastroscope The EG-550 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor…
Read the full statement (192 words)
HD-550 Video Endoscope System
The HD-550 video endoscope system, which includes a video gastroscope /video colonoscope, image processor, light source, monitor, accessories and other peripheral devices, is intended for endoscopic examination, diagnosis and treatment of the upper and lower gastrointestinal tract.
EG-550 Series Video Gastroscope
The EG-550 Series Video Gastroscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the upper digestive tract (including the esophagus, stomach and duodenum).
EC-550 Series Video Colonoscope
The EC-550 Series Video Colonoscope has been designed to be used with the image processor, light source, monitor and other peripheral devices for endoscopic observation, diagnosis and treatment of the lower digestive tract (including the anus, rectum, colon and ileocecal segment).
HD-550 Series Image Processor
The HD-550 Series Image Processor has been designed to be used with the endoscope, light source, monitor and other peripheral devices for endoscopic observation, diagnosis, treatment, and video recording.
VLS-55 Series Light Source
The VLS-55 Series Light Source has been designed to be used with the endoscope, image processor and other peripheral devices for endoscopic observation, diagnosis and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211882 · printed Nov 3, 2026
Cite this page
510(k) Report. “K211882: HD-550 Video Endoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K211882
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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