# K012029: Remedy Model 2Z12

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Corp.
- Decided: Dec 31, 2001 after 186 days
- Product code: KMG (Purifier, Water, Ultraviolet, Medical)
- Device class: 2
- Regulation: 21 CFR 880.6710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813050 (1981). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813050: Aquanomics, #MP4SF, Cooper-Hewitt Electric Co. (1981). 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”.
- K813049: Aquanomics, #HHU100, Cooper-Hewitt Electric Co. (1981) Summary page 1.
- K813048: Aquanomics, #MP2SF, Cooper-Hewitt Electric Co. (1981) Summary page 1.
- K813047: Aquanomics, Mini 60L, Cooper-Hewitt Electric Co. (1981) Summary page 1.
- K813046: Aquanomics, #HHU60, Cooper-Hewitt Electric Co. (1981) Summary page 1.
- K813045: Aquanomics, #SP36SF, Cooper-Hewitt Electric Co. (1981) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K012029
Methodology: https://510kreport.com/methodology