510(k) · Cleared
ClearedNevoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nizar A. Mullani · KZF Device, Medical Examination, Ac Powered
Cleared on Mar 27, 1996 as substantially equivalent to K920103 (Welch Allyn, Inc., 1992) after a 149-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 27, 1996
- Review
- 149 days
- Class
- Class I
- Product code
- KZF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920103 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920103 Episcope, Model 47300Welch Allyn, Inc. · 1992
- This deviceK954943 NevoscopeNizar A. Mullani · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920103 | Episcope, Model 47300 | Welch Allyn, Inc. | 1992 | — |
| 0 (this device) | K954943 | Nevoscope | Nizar A. Mullani | 1996 | — |
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 KZF? 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 |
|---|---|---|---|
| * | K920103 | Episcope, Model 47300Summary page 1…f SMDA 1990 and 21 CFR 807.92 The assigned 510(k) number is : IS 4943 Nevoscope is a hand-held, skin examination microscope that is similar in concept to the Episcope (k920103) and the Dermatoscope devices approved by the FDA. It is a non invasive device that is designed to view skin lesions by either su… | 1992 |
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 KZF devicesKZF Device, Medical Examination, Ac Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZF
FDA has decided no KZF device since 2007.
Median 510(k) review, days · KZF
Too few KZF 510(k)s in any year since 2007 to give a median.
Recalls per year · KZF
No recall names KZF since 2007.
Adverse event reports per year · KZF
9in 2025
MAUDE reports naming product code KZF, 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 | 10 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 27 |
| 2020 | 0 | — | 0 | 47 |
| 2021 | 0 | — | 0 | 21 |
| 2022 | 0 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 83 |
| 2024 | 0 | — | 0 | 20 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Nevoscope is a hand-held, skin examination microscope that is designed to view skin lesions by either surface illumination or transillumination.
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/K954943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954943: Nevoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954943
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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