510(k) Report

510(k) · Cleared

Cleared

Toilet Seat Raised

K830425510(k) TraditionalCleared May 9, 198389-day reviewClass I21 CFR 890.5050

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

Maddak, Inc. · ILS Adaptor, Hygiene

Cleared on May 9, 1983 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 9, 1983
Review
89 days
Class
Class I
Product code
ILS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K830425Source: FDA 510(k) database · How lineage is built

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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.

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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 ILS devices

ILS Adaptor, Hygiene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILS

FDA has decided no ILS device since 2007.

Median 510(k) review, days · ILS

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

Recalls per year · ILS

No recall names ILS since 2007.

Adverse event reports per year · ILS

46in 2025

2009: 12010: 62011: 212012: 1142013: 5532014: 7052015: 7022016: 4112017: 482018: 362019: 502020: 322021: 272022: 452023: 592024: 372025: 46
2007high 705 (2014) · low 0 (2007)2025

MAUDE reports naming product code ILS, 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—01
20100—06
20110—021
20120—0114
20130—0553
20140—0705
20150—0702
20160—0411
20170—048
20180—036
20190—050
20200—032
20210—027
20220—045
20230—059
20240—037
20250—046
20260—0—

More from Maddak, Inc.

51 FDA decisions under this applicant name. See the company

  • K841700Walk & RollMaddak, Inc. · 1984
  • K841698Heat PackMaddak, Inc. · 1984
  • K841695CrawlerMaddak, Inc. · 1984
  • K841692Prone StanderMaddak, Inc. · 1984
  • K841693Standing FrameMaddak, Inc. · 1984

Recent decisions in ILS

The ILS category page

  • K852049Medical Toilet SeatPedro Aleman · 1985
  • K842651Commode Chair 98200Guardian Products Co., Inc. · 1984
  • K830853Lavatory Seat HeightenerLic-Orthion · 1983
  • K831547Raised Toilet Seats & Nail ClippersFred Sammons, Inc. · 1983
  • K830852Shower Stool W/HandlesLic-Orthion · 1983

https://510kreport.com/device/K830425 · printed Nov 4, 2026

Cite this page

510(k) Report. “K830425: Toilet Seat Raised.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K830425

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