510(k) · Cleared
ClearedPoc Ent Endoscope - Sinuscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Optics Corp. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Sep 25, 1998 as substantially equivalent to K945684 (Precision Optics Corp., 1995) after an 86-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 25, 1998
- Review
- 86 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945684 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945684 Poc Arthroscope and AccessoriesPrecision Optics Corp. · 1995
- This deviceK983123 Poc Ent Endoscope - SinuscopePrecision Optics Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945684 | Poc Arthroscope and Accessories | Precision Optics Corp. | 1995 | — |
| 0 (this device) | K983123 | Poc Ent Endoscope - Sinuscope | Precision Optics Corp. | 1998 | — |
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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K914084 | FDA’s K914084 is Endoscopes Our OCR of the scanned summary read K914084, FDA’s number for Endoscopes (Precise Optics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Laparoscope”. Kept off the family tree. Summary page 1…dentical with respect to external materials, construction, and fundamental operational principles to Precision Optics Corporation’s current line of cleared Laparoscopes (K914084) and Arthroscopes (K945684) except for variations of tube diameter and insertion length. Page 7-1 3 R P —~ ;-… | 1992 |
| * | K945684 | Poc Arthroscope and AccessoriesSummary page 1…ternal materials, construction, and fundamental operational principles to Precision Optics Corporation’s current line of cleared Laparoscopes (K914084) and Arthroscopes (K945684) except for variations of tube diameter and insertion length. Page 7-1 3 R P —~ ;- + (~VR ot WEALTH K sem… | 1995 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 4 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
What is it indicated for?
Precision Optics Corporation’s ENT Endoscopes - Sinuscopes are indicated for use to examine or treat the nasal cavity and nasal pharynx by providing illumination and visualization of these regions.
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/K983123 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983123: Poc Ent Endoscope - Sinuscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983123
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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