510(k) · Cleared

Cleared

Sony Color Video Cameras and Accessories

K884343510(k) TraditionalCleared Nov 1, 198818-day reviewClass I21 CFR 878.4160

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

Sony Corp. of America · FWB Camera, Television, Surgical, Without Audio

Cleared on Nov 1, 1988 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Nov 1, 1988
Review: 18 days
Class: Class I
Product code: FWB
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK884343 Sony Color Video Cameras and AccessoriesSony Corp. of America · 1988
Descendant · cites it directly · 0 of its ownK980279 Sony DXC-LS1 Color Video CameraSony Medical Electronics Co. · 1998

Most influential descendants

Showing 1 of 1 · See all

K980279Sony DXC-LS1 Color Video CameraSony Medical Electronics Co. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884343	Sony Color Video Cameras and Accessories	Sony Corp. of America	1988	—
+1	K980279	Sony DXC-LS1 Color Video Camera	Sony Medical Electronics Co.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K884343, 1988–1998Source: FDA 510(k) summaries, read by 510(k) Report · 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 FWB? 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K980279	Sony DXC-LS1 Color Video Camera	Sony Medical Electronics Co.	1998	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?

Of its descendants, K980279 (Sony Medical Electronics Co., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FWB devices

FWB Camera, Television, Surgical, Without Audio: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FWB

FDA has decided no FWB device since 2007.

Median 510(k) review, days · FWB

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

Recalls per year · FWB

1in 2017

2007high 1 (2017) · low 0 (2007)2026

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

Adverse event reports per year · FWB

5in 2025

2007high 30 (2010) · low 0 (2007)2025

MAUDE reports naming product code FWB, 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	2
2009	—	0	4
2010	—	0	30
2011	—	0	22
2012	—	0	10
2013	—	0	5
2014	—	0	7
2015	—	0	6
2016	—	0	11
2017	—	1	3
2018	—	0	4
2019	—	0	4
2020	—	0	13
2021	—	0	6
2022	—	0	1
2023	—	0	11
2024	—	0	6
2025	—	0	5
2026	—	0	—

https://510kreport.com/device/K884343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884343: Sony Color Video Cameras 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/K884343

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026