510(k) Report

510(k) · Cleared

Cleared

Surgeons Cap

K882284510(k) TraditionalCleared Jun 23, 198823-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

A Plus International, Inc. · FYF Cap, Surgical

Cleared on Jun 23, 1988 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 23, 1988
Review
23 days
Class
Class I
Product code
FYF
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882284Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 FYF? 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 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 FYF devices

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

FDA decisions per year · FYF

FDA has decided no FYF device since 2007.

Median 510(k) review, days · FYF

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

Recalls per year · FYF

No recall names FYF since 2007.

Adverse event reports per year · FYF

1in 2021

2010: 12011: 22012: 22014: 32015: 32016: 22018: 32021: 1
2007high 3 (2014) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—02
20120—02
20130—00
20140—03
20150—03
20160—02
20170—00
20180—03
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from A Plus International, Inc.

11 FDA decisions under this applicant name. See the company

  • K213001Procedure Mask, Surgical MaskA Plus International, Inc. · 2022
  • K102861Surgiplus SMS Surgical Drape (Sterile/Non-Sterile), Surgiplus SPP with PE Laminated Surgical Drape…A Plus International, Inc. · 2011
  • K093169Surgiplus Standard Surgical Gown (Sterile) ( Non Sterile), Reinforced Surgical Gown (Sterile) (Non Sterile)A Plus International, Inc. · 2009
  • K031353Solution Face MasksA Plus International, Inc. · 2003
  • K882281Gown, Isolation, Surgical (Fyc)A Plus International, Inc. · 1988

Recent decisions in FYF

The FYF category page

  • K972227Shoe CoverAmerican Seal Co. · 1997
  • K955833Niomed Surgical CapsAmerasia Corp. · 1996
  • K954556Surgical CapThai Disposable Products Co., Ltd. · 1996
  • K954454Niomed Surgical HoodAmerasia Corp. · 1996
  • K954455Niomed Bouffant CapsAmerasia Corp. · 1996

https://510kreport.com/device/K882284 · printed Nov 4, 2026

Cite this page

510(k) Report. “K882284: Surgeons Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K882284

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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