510(k) Report

510(k) · Cleared

Cleared

Cersa-Cane

K790558510(k) TraditionalCleared Apr 3, 197915-day reviewClass I21 CFR 890.3075

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

Maddak, Inc. · IPS Cane

Cleared on Apr 3, 1979 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 3, 1979
Review
15 days
Class
Class I
Product code
IPS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K790558Source: 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 IPS? 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 IPS devices

IPS Cane: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPS

FDA has decided no IPS device since 2007.

Median 510(k) review, days · IPS

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

Recalls per year · IPS

No recall names IPS since 2007.

Adverse event reports per year · IPS

7in 2025

2007: 42008: 42009: 72010: 52011: 172012: 552013: 592014: 962015: 222016: 212017: 172018: 132019: 82020: 42021: 112022: 102023: 182024: 52025: 7
2007high 96 (2014) · low 4 (2007)2025

MAUDE reports naming product code IPS, 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—04
20080—04
20090—07
20100—05
20110—017
20120—055
20130—059
20140—096
20150—022
20160—021
20170—017
20180—013
20190—08
20200—04
20210—011
20220—010
20230—018
20240—05
20250—07
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
  • K841697Hydro-Thero PadMaddak, Inc. · 1984
  • K841693Standing FrameMaddak, Inc. · 1984

Recent decisions in IPS

The IPS category page

  • K832969Walking CaneMaddak, Inc. · 1983
  • K832970Cane ReacherMaddak, Inc. · 1983
  • K821402Light Weight Aluminum CanesManuco Manufacturing Co., Inc. · 1982
  • K790561Offset Aluminum CaneMaddak, Inc. · 1979
  • K790299Forearm-CaneGuardian Products Co., Inc. · 1979

https://510kreport.com/device/K790558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K790558: Cersa-Cane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K790558

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