Multiple Scrub Suit

K822483510(k) TraditionalCleared Sep 17, 198231-day reviewClass I21 CFR 878.4040

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

Surgilite Intl., Inc. · FXO Suit, Surgical

Cleared on Sep 17, 1982 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Sep 17, 1982
Review: 31 days
Class: Class I
Product code: FXO
Recalls: None
Predicates: 0

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

FIG. 1 — Lineage of K822483Source: 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 FXO? 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?

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 FXO devices

FXO Suit, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FXO

FDA has decided no FXO device since 2007.

Median 510(k) review, days · FXO

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

Recalls per year · FXO

No recall names FXO since 2007.

Adverse event reports per year · FXO

No MAUDE report names FXO since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K822483 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822483: Multiple Scrub Suit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822483

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Record history

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