510(k) Report

510(k) · Cleared

Cleared

Sterile Cast Padding

K801554510(k) TraditionalCleared Aug 4, 198027-day reviewClass I21 CFR 886.1435

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

Medi-Spec · HIX Maxwell Spot, Ac-Powered

Cleared on Aug 4, 1980 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 4, 1980
Review
27 days
Class
Class I
Product code
HIX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801554Source: 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.

Planning a device in HIX? 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 HIX devices

HIX Maxwell Spot, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HIX

FDA has decided no HIX device since 2007.

Median 510(k) review, days · HIX

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

Recalls per year · HIX

No recall names HIX since 2007.

Adverse event reports per year · HIX

No MAUDE report names HIX since 2007.

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

More from Medi-Spec

8 FDA decisions under this applicant name. See the company

  • K833068Laminaria Japonica Cervical DilatorMedi-Spec · 1984
  • K812694Whisk-RMedi-Spec · 1981
  • K812426Uterine Aspiration Curettes (Rigid&Flex)Medi-Spec · 1981
  • K800404Medspec Operative Opthalmic KitMedi-Spec · 1980
  • K800490Sterile Dressing PackMedi-Spec · 1980

Recent decisions in HIX

The HIX category page

  • K831829Karickhoff Flying Corpuscle ViewerSurgidev Corp. · 1983

https://510kreport.com/device/K801554 · printed Nov 4, 2026

Cite this page

510(k) Report. “K801554: Sterile Cast Padding.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801554

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