510(k) · Cleared
ClearedErgo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jedmed Instrument Co. · EQN Laryngoscope, Nasopharyngoscope
Cleared on Feb 21, 2014 as substantially equivalent to K992526 (Richard Wolf Medical Instruments Corp., 1999) after a 234-day review. Its family tree reaches back 3 generations to 1996. 1 later device descends from it.
- Decided
- Feb 21, 2014
- Review
- 234 days
- Class
- Class II
- Product code
- EQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K962172 (1996). 5 ancestors in all, the oldest K921707 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK962172 Flexible Mini-FiberscopesRichard Wolf Medical Instruments Corp. · 1996
- 2 generations backK980401 Flexible Fiberscopes and AccessoriesRichard Wolf Medical Instruments Corp. · 1998
- 1 generation backK992526 Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeRichard Wolf Medical Instruments Corp. · 1999
- This deviceK132039 Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N SlimJedmed Instrument Co. · 2014
- Descendant · cites it directly · 0 of its ownK150248 ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015
Most influential descendants
Showing 1 of 1 · See all- K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962172 | Flexible Mini-Fiberscopes | Richard Wolf Medical Instruments Corp. | 1996 | — |
| −2 | K980401 | Flexible Fiberscopes and Accessories | Richard Wolf Medical Instruments Corp. | 1998 | — |
| −1 | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible Bronchoscope | Richard Wolf Medical Instruments Corp. | 1999 | — |
| 0 (this device) | K132039 | Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim | Jedmed Instrument Co. | 2014 | — |
| +1 | K150248 | ORL Video NasoPharyngo-Larngoscope | Jedmed Instrument Company | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K992526 | Flexible Nasopharyngo-Laryngoscopes, Flexible BronchoscopeSummary page 1…nd flexible bronchoscope to which Equivalence is Richard Wolf Medical Instruments Corp. Claimed: (Premarket notification K992526) Description: This flexible scope is designed with the insertion tube with its bendlable distal tip… | 1999 |
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 |
|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-Larngoscope | 2015 | 0 |
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 18 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K150248 (Jedmed Instrument Company, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992526.
How does its category compare?
All EQN devicesEQN Laryngoscope, Nasopharyngoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
JEDMEDs Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx.
They are used between the upper respiratory tracts of the nasal passage and the vocal cards.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132039: Ergo-Flex Laryngo-Nasopharyngoscope EF-N and EF-N Slim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132039
Report an extraction error
Are you the manufacturer?
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