# K030789: Amsco Century Steam Sterilizer

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Mar 26, 2003 after 14 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: 4 generations back to K820783 (1982). 5 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 14 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.
- K012573: Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and 533HC, Getinge/Castle, Inc. (2001) Summary page 1.

## Most influential descendants
- K111223: Amsco Chimeron Small Steam Sterilizer (2011), 3 descendants of its own
- K120149: Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura Steam Sterilizer Assv-AB09 Sakura (2012), 2 descendants of its own
- K221474: PRIMUS Healthcare Sterilizer (Model PSS11-HC) (2023), 1 descendant of its own
- K233132: PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) (2023), 0 descendants of its own
- K212424: AMSCO 400 Small Steam Sterilizers,  AMSCO 400 Medium Steam Sterilizers (2021), 0 descendants of its own

## Indications for use
The Am~coCentury Steam Sterilizer is designed for efficient steriltzation of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Amsco Century Steam Sterilizer is available in the following configurations: 16” x 16” x 26” Single Door Gravity* 16” x 16” x 26” Single Door Prevacuum 16” x 16” x 26” Double Door Gravity 16” x 16” x 26” Double Door Prevacuum 20” x 20” x 38” Single Door Gravity 20” x 20” x 38” Single Door Prevacuum 20” x 20’’ x 38” Double Door Gravity 20” x 20” x 38” Double Door Prevacuum *Note: No changes are being made to the gravity sterilizers program. The Amsco Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cyde values: Cycle — Recommended Loads — Stetilize Temp — Sterilize Time — Dry Time Flash — Unwrapped instrument tray with a single instrument — 270°F (132°C) — 3 minutes — 1 minute Flash — Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. — 270°F (1 32OC) — 10 minutes — 1 minute Express — Single wrapped instrument tray with a single instrument. Non-porous goods only. — 270°F (132°C) — 4 minutes — 3 minutes Prevac — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. Up to six fabric packs. — 270°F (132°C) — 4 minutes — 20 minutes’ Prevac — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray. — 275°F (135°C) — 3 minutes — 16 minutes Cycle — Recommended Loads — Sterilize Temp — Sterilize Time — Dry Time Flash — Unwrapped instrument tray with a single instrument — 270°F (132°C) — 3 minutes Flash — Unwrapped instrument tray with multiple non-porous instruments, maximum weight 17 pounds per tray. — 270°F (132OC) — 10 minutes Gravity — Up to two double wrapped instrument trays, maximum weight 17 pounds per tray — 270°F (132°C) — 15 minutes Gravity — Fabric Packs u,p-b5 ; xr r d - ~ f /&b — 250°F (121°C) — 30 minutes2

Source page: https://510kreport.com/device/K030789
Methodology: https://510kreport.com/methodology