# K021223: Belimed Steam Sterilizer, Model Top 5000

- Pathway: 510(k) (Traditional)
- Applicant: Sauter AG
- Decided: Jun 26, 2002 after 69 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- 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 K964332 (1998). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964332: Eagle Century Steam Sterilizer, Amsco Intl., Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K011086: Hardydisk Bacitracin, 10MCG, Model Z927, Hardy Diagnostics (2001). Our reading of the summary gave K011086, FDA’s number for Hardydisk Bacitracin, 10MCG, Model Z927 (Hardy Diagnostics). Its FDA name has none of the distinctive words the summary uses for the device it names, “Amsco Century Medium Steam Sterilizer”. Kept off the family tree.

## Most influential descendants
- K170228: Belimed Steam Sterilizer MST-H TOP 5000 (2017), 1 descendant of its own
- K191896: Belimed Steam Sterilizer MST-H TOP 5000 (2019), 0 descendants of its own
- K141879: Belimed Steam Sterilizer MST-H (2015), 0 descendants of its own
- K072087: Belimed Steam Sterilizer Model Top 5000 Series 24 (2007), 0 descendants of its own

## Indications for use
The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

Source page: https://510kreport.com/device/K021223
Methodology: https://510kreport.com/methodology