510(k) · Cleared
ClearedKARL STORZ Laryngoscopes and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EQN Laryngoscope, Nasopharyngoscope
Cleared on May 15, 2026 as substantially equivalent to K953771 (KARL STORZ Endoscopy-America, Inc., 1995) after a 270-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 15, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- EQN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K953771 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK953771 Operating Laryngoscopes & Accessories Forceps, ProtectorsKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK252624 KARL STORZ Laryngoscopes and AccessoriesKARL STORZ Endoscopy-America, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953771 | Operating Laryngoscopes & Accessories Forceps, Protectors | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K252624 | KARL STORZ Laryngoscopes and Accessories | KARL STORZ Endoscopy-America, Inc. | 2026 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K953771 | Operating Laryngoscopes & Accessories Forceps, ProtectorsSummary page 6…ss: Product Code: EQN Classification 874.4760 - Nasopharyngoscope (flexible or rigid) and accessories. Name: Device Panel: Ear Nose & Throat Predicate K953771 – KARL STORZ Laryngoscopes & Accessories Device: The predicate device has not been subject to any recalls. Refe… | 1995 |
| † | K944295 | Karl Storz Laryngoscope Accessories | 1994 |
| † | K945237 | Karl Storz Suctyion/Irrigation Tubes, Cannulae | 1994 |
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 EQN devicesEQN Laryngoscope, Nasopharyngoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Laryngoscopes: Model Numbers 8576A, 8576B, 8576C, 8576CC, 8576D, 8576E, 8587KK, 8588B, 8588BV, 8590K, 8590L KARL STORZ distending and non-distending laryngoscopes and accessories are intended to create a working channel for minimally invasive investigations and treatments of the larynx for adult and pediatric patients. Models with a suction device connection are also used for suction. Model Numbers 8574B, 8574C, 8574D, 8574E, 8574G, 8574JP, 8574SL…
Read the full statement (259 words)
Laryngoscopes:
Model Numbers 8576A, 8576B, 8576C, 8576CC, 8576D, 8576E, 8587KK, 8588B, 8588BV, 8590K, 8590L
KARL STORZ distending and non-distending laryngoscopes and accessories are intended to create a working channel for minimally invasive investigations and treatments of the larynx for adult and pediatric patients. Models with a suction device connection are also used for suction.
Model Numbers 8574B, 8574C, 8574D, 8574E, 8574G, 8574JP, 8574SL, 8574SLS, 8574SSL, 8576AA, 8580B, 8582B, 8583B, 8587A, 8587AA, 8588A, 8589B, 8589C, 8590A, 8590AL, 8590B, 8590BL, 8590C, 8590CL, 8590DL, 8590DN, 8590J, 8590JA, 8590JL, 8590JV, 8590TV, 8661AN, 8661CN, 8661DN, 8661EN, 8666AN, 8666DN, 8668A, 8790A, 8790B, 8890A
KARL STORZ distending and non-distending laryngoscopes and accessories are intended to create a working channel for minimally invasive investigations and treatments of the larynx for adult patients. Models with a suction device connection are also used for suction.
Suction/Irrigation Tubes:
Model Numbers 8602KK, 8602KS, 8603KS, 8604KK
KARL STORZ suction/irrigation tubes are used with KARL STORZ distending and non-distending laryngoscopes. KARL STORZ suction/irrigation tubes are used in minimally invasive investigations and treatments of the larynx for adult and pediatric patients.
Model Numbers 8602, 8603, 8604, 8602A, 8602K, 8602KA, 8602KV, 8603A, 8603K, 8603KA, 8603KV, 8604A, 8604E, 8691A, 8691B, 8691C, 8692A, 8692B, 8692C
KARL STORZ suction/irrigation tubes are used with KARL STORZ distending and non-distending laryngoscopes. KARL STORZ suction/irrigation tubes are used in minimally invasive investigations and treatments of the larynx for adult patients.
Supporting Devices:
KARL STORZ supporting devices are used with KARL STORZ distending and non-distending laryngoscopes. KARL STORZ supporting devices are intended for holding and supporting laryngoscopes for adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252624: KARL STORZ Laryngoscopes and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252624
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026