510(k) · Cleared

Cleared

Medical Monitor (32MD08WC)

K262985510(k) TraditionalCleared Oct 2, 202636-day reviewClass II21 CFR 892.2050

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

Lg Electronics.Inc · PGY Display, Diagnostic Radiology

Cleared on Oct 2, 2026 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Oct 2, 2026
Review: 36 days
Class: Class II
Product code: PGY
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K262985Source: 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 PGY? 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 PGY device

#1 K261213 Medical Monitor (40HT513D)score 13.9 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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?

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 PGY devices

PGY Display, Diagnostic Radiology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · PGY

3in 2025

2007high 18 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGY

59in 2025

2007high 77 (2021) · low 24 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · PGY

No recall names PGY since 2007.

Adverse event reports per year · PGY

1in 2017

2007high 1 (2017) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	14	24	0
2015	16	31	0
2016	18	27	0
2017	11	30	1
2018	5	28	0
2019	11	58	0
2020	12	61	0
2021	7	77	0
2022	10	60	0
2023	17	60	0
2024	10	53	0
2025	3	59	0
2026	4	48	—

https://510kreport.com/device/K262985 · printed Nov 6, 2026

Cite this page

510(k) Report. “K262985: Medical Monitor (32MD08WC).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262985

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Record history

FDA decision record loaded Oct 30, 2026
Page last updated Nov 3, 2026