510(k) · Cleared
ClearedMahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mahe Intl., Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Oct 16, 2003 as substantially equivalent to K945381 (KARL STORZ Endoscopy-America, Inc., 1995) after a 212-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Oct 16, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945381 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK945381 Nasopharyngoscopes, Bronchoscopes, Tracheoscp[ES and Esophagoscopes…KARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK030857 Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary…Mahe Intl., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK171402 KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171402KARL STORZ Slim NasopharyngolaryngoscopeKARL STORZ Endoscopy-America, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945381 | Nasopharyngoscopes, Bronchoscopes, Tracheoscp[ES and Esophagoscopes… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K030857 | Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and… | Mahe Intl., Inc. | 2003 | — |
| +1 | K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | KARL STORZ Endoscopy-America, Inc. | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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? (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 |
|---|---|---|---|
| * | K945381 | Nasopharyngoscopes, Bronchoscopes, Tracheoscp[ES and Esophagoscopes, Laryngoscopes…Summary page 1…ediatric Naso-Pharyngoscope and Accessories PREDICATE DEVICES KARL STORZ NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) K945381 SUBMITTED BY: Paul Cart MAHE International Inc… | 1995 |
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 |
|---|---|---|---|
| K171402 | KARL STORZ Slim Nasopharyngolaryngoscope | 2018 | 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?
- Its one ancestor has no recall.
- Of its descendants, K171402 (KARL STORZ Endoscopy-America, Inc., 2018) has gone furthest, with 0 descendants of its own.
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?
The MAHE International Pediatric NASOPHARYNGOSCOPE is indicated for visual examination during a diagnostic and therapeutic procedure within the nasal cavity and nasal pharynx.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030857: Mahe Pediatric Naso Pharyngoscope Its Associated and Ancillary Equipment and Endoscopic Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030857
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