510(k) · Cleared
ClearedORL Video NasoPharyngo-Larngoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jedmed Instrument Company · EQN Laryngoscope, Nasopharyngoscope
Cleared on Jul 23, 2015 as substantially equivalent to K132039 (Jedmed Instrument Co., 2014) and 1 other predicate after a 170-day review. Its family tree reaches back 8 generations to 1983.
- Decided
- Jul 23, 2015
- Review
- 170 days
- Class
- Class II
- Product code
- EQN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K833587 (1983). 62 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 8 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 7 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 6 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 5 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 4 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 3 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 2 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 1 generation backK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- This deviceK150248 ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −7 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −6 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −5 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −4 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −3 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −2 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −1 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| 0 (this device) | K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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 EQN? 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 EQN device
- #1 K252624 KARL STORZ Laryngoscopes and Accessoriesscore 11.3 · 1 generation · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132039 | Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimSummary page 4…r: 874.4760 Legally Marketed Device Flexible naso-pharyngo-laryngoscope to which Equivalence is claimed JEDMED Instrument Company K132039 ERGOFLEX NasoPharyngolaryngoscope Vision Science Flexible ENT 5000… | 2014 |
| * | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Summary page 4…JEDMED Instrument Company K132039 ERGOFLEX NasoPharyngolaryngoscope Vision Science Flexible ENT 5000 K102733 Claimed: Description: This flexible scope is designed with the insertion tube with its bendable distal tip… | 2011 |
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 32 years and passes through 7 companies; a new generation was cleared every 4.2 years on median.
- 6 of the 62 ancestors have a recall of any class.
How does its category compare?
All EQN devicesEQN Laryngoscope, Nasopharyngoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EQN
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · EQN
Too few EQN 510(k)s in any year since 2007 to give a median.
Recalls per year · EQN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EQN
3in 2020
MAUDE reports naming product code EQN, 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 | 6 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx.
They are used between the upper respiratory tracts of the nasal passage and vocal cords.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150248: ORL Video NasoPharyngo-Larngoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150248
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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