510(k) Report

510(k) · Cleared

Cleared

Remedy Model 2Z12

K012029510(k) TraditionalCleared Dec 31, 2001186-day reviewClass II21 CFR 880.6710

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

Apollo Corp. · KMG Purifier, Water, Ultraviolet, Medical

Cleared on Dec 31, 2001 as substantially equivalent to K813050 (Cooper-Hewitt Electric Co., 1981) and 5 other predicates after a 186-day review. Its family tree reaches back 1 generation to 1981.

Decided
Dec 31, 2001
Review
186 days
Class
Class II
Product code
KMG
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K813050 (1981). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1981: 5 other ancestorsK813050 · Aquanomics, #MP4SF · Cooper-Hewitt Electric Co. · 198119801985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors K813050 · Aquanomics, #MP4SF · Cooper-Hewitt Electric Co. · 19810
  1. Root · 1 generation backK813050 Aquanomics, #MP4SFCooper-Hewitt Electric Co. · 1981
  2. This deviceK012029 Remedy Model 2Z12Apollo Corp. · 2001
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K813050Aquanomics, #MP4SFCooper-Hewitt Electric Co.1981—
0 (this device)K012029Remedy Model 2Z12Apollo Corp.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198150
FIG. 1 — Lineage of K012029, 1981–2001Source: FDA 510(k) summaries, read by 510(k) Report · 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KMG? 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? (6)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K813050Aquanomics, #MP4SF
Our OCR of the scanned summary read K813060, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aquanomics MP4SF”.
Cooper-Hewitt Electric Co.1981—
*K813049Aquanomics, #HHU100
Summary page 1
…lly equivalent and subject to Pre-Market Notification (PN numbers listed below) are all manufactured by Cooper-Hewitt Electric Company bearing model numbers: HHU100 (PN #K813049), MP2SF (PN #K813048), MINI 60L (PN #K813047), HHUGB0 (PN 3 K813046), and SP36SF (PN K813045). V-1 Apolio Corpor…
Cooper-Hewitt Electric Co.1981—
*K813048Aquanomics, #MP2SF
Summary page 1
…bject to Pre-Market Notification (PN numbers listed below) are all manufactured by Cooper-Hewitt Electric Company bearing model numbers: HHU100 (PN #K813049), MP2SF (PN #K813048), MINI 60L (PN #K813047), HHUGB0 (PN 3 K813046), and SP36SF (PN K813045). V-1 Apolio Corporation 510(k) Descrip…
Cooper-Hewitt Electric Co.1981—
*K813047Aquanomics, Mini 60L
Summary page 1
…fication (PN numbers listed below) are all manufactured by Cooper-Hewitt Electric Company bearing model numbers: HHU100 (PN #K813049), MP2SF (PN #K813048), MINI 60L (PN #K813047), HHUGB0 (PN 3 K813046), and SP36SF (PN K813045). V-1 Apolio Corporation 510(k) Description of Device: Intende…
Cooper-Hewitt Electric Co.1981—
*K813046Aquanomics, #HHU60
Summary page 1
…sted below) are all manufactured by Cooper-Hewitt Electric Company bearing model numbers: HHU100 (PN #K813049), MP2SF (PN #K813048), MINI 60L (PN #K813047), HHUGB0 (PN 3 K813046), and SP36SF (PN K813045). V-1 Apolio Corporation 510(k) Description of Device: Intended Use: 11/01/2001 Apo…
Cooper-Hewitt Electric Co.1981—
*K813045Aquanomics, #SP36SF
Summary page 1
…actured by Cooper-Hewitt Electric Company bearing model numbers: HHU100 (PN #K813049), MP2SF (PN #K813048), MINI 60L (PN #K813047), HHUGB0 (PN 3 K813046), and SP36SF (PN K813045). V-1 Apolio Corporation 510(k) Description of Device: Intended Use: 11/01/2001 Apollo’s Remedy® is a device…
Cooper-Hewitt Electric Co.1981—

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.

What does this lineage say?

  • None of the 6 ancestors has a recall.

How does its category compare?

All KMG devices

KMG Purifier, Water, Ultraviolet, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMG

FDA has decided no KMG device since 2007.

Median 510(k) review, days · KMG

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

Recalls per year · KMG

No recall names KMG since 2007.

Adverse event reports per year · KMG

No MAUDE report names KMG 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—

What is it indicated for?

Apollo’s Remedy® is intended for use as an optional accessory with Apollo whirlpool bathing systems in which patients in healthcare facilities are bathed. This device is not intended to be sold as a separate, stand-alone device. The Remedy UV Water Purifier 2Z12 is a device that is intended for use only as an accessory on Apollo whirlpool bathing systems.

The Apollo Remedy® is designed to reduce bacteria levels in bath water during the bathing cycle.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in KMG

The KMG category page

  • K832288HemoglobinometerMallinckrodt Critical Care · 1983
  • K831253Lancer Hemoglobin Analyzer ReagentsSherwood Medical Co. · 1983
  • K813049Aquanomics, #HHU100Cooper-Hewitt Electric Co. · 1981
  • K813046Aquanomics, #HHU60Cooper-Hewitt Electric Co. · 1981
  • K813050Aquanomics, #MP4SFCooper-Hewitt Electric Co. · 1981

https://510kreport.com/device/K012029 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012029: Remedy Model 2Z12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012029

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
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026