Som 6VI (Surgical Operating Microscope)

K926288510(k) TraditionalCleared Oct 12, 1993302-day reviewClass I21 CFR 878.4700

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jedmed Instrument Co. · FSO Microscope, Surgical, General & Plastic Surgery

Cleared on Oct 12, 1993 after a 302-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided: Oct 12, 1993
Review: 302 days
Class: Class I
Product code: FSO
Recalls: None
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K926288Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FSO? 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

How does its category compare?

All FSO devices

FSO Microscope, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FSO

FDA has decided no FSO device since 2007.

Median 510(k) review, days · FSO

Too few FSO 510(k)s in any year since 2007 to give a median.

Recalls per year · FSO

1in 2023

2007high 2 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FSO

17in 2025

2007high 19 (2021) · low 0 (2007)2025

MAUDE reports naming product code FSO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	2	2
2011	—	0	1
2012	—	1	2
2013	—	0	2
2014	—	0	7
2015	—	0	10
2016	—	0	12
2017	—	0	14
2018	—	0	11
2019	—	0	12
2020	—	0	7
2021	—	1	19
2022	—	0	5
2023	—	1	17
2024	—	0	15
2025	—	0	17
2026	—	0	—

https://510kreport.com/device/K926288 · printed Nov 4, 2026

Cite this page

510(k) Report. “K926288: Som 6VI (Surgical Operating Microscope).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926288

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026