510(k) · Cleared
ClearedObp Self Sealing Endoscopic Seal with Luer Lock
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Obp Medical · HIH Hysteroscope (And Accessories)
Cleared on Dec 4, 2009 after a 165-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Dec 4, 2009
- Review
- 165 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK091838 Obp Self Sealing Endoscopic Seal with Luer LockObp Medical · 2009
- Descendant · cites it directly · 3 of its ownK173105 Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst…Cook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK252933 Dyne PortDyne Medical Group, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241842 Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK211814 Wellead Endoscopic SealWell Lead Medical Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK181712 San Antonio StopcockCook Incorporated · 2018
Most influential descendants
Showing 5 of 5 · See all- K173105Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst AdapterCook Incorporated · 2018 · cites it directly3descendants
- K252933Dyne PortDyne Medical Group, Inc. · 2026 · 2 generations on0descendants
- K241842Luer-Split MAJ-2092Olympus Medical Systems Corporation · 2025 · 2 generations on0descendants
- K211814Wellead Endoscopic SealWell Lead Medical Co., Ltd. · 2022 · cites it directly0descendants
- K181712San Antonio StopcockCook Incorporated · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091838 | Obp Self Sealing Endoscopic Seal with Luer Lock | Obp Medical | 2009 | — |
| +1 | K173105 | Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter | Cook Incorporated | 2018 | — |
| +2 | K252933 | Dyne Port | Dyne Medical Group, Inc. | 2026 | — |
| +2 | K241842 | Luer-Split MAJ-2092 | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K211814 | Wellead Endoscopic Seal | Well Lead Medical Co., Ltd. | 2022 | — |
| +2 | K181712 | San Antonio Stopcock | Cook Incorporated | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
Planning a device in HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K173105 (Cook Incorporated, 2018) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The OBP Self-Sealing Endoscopic Seal is a single use, sterile endoscopic introducer seal. It is affixed to the proximal port of the endoscope working channel. It prevents efflux of distention fluid when the channel is not being used or when instruments are passed through the working channel of the endoscope. The seal may be used with following types of endoscopes:
hysteroscope
laparoscope
cystoscope
colonoscope
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/K091838 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091838: Obp Self Sealing Endoscopic Seal with Luer Lock.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091838
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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