# K964332: Eagle Century Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Amsco Intl., Inc.
- Decided: Jun 1, 1998 after 579 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K030789: Amsco Century Steam Sterilizer (2003), 8 descendants of its own
- K021223: Belimed Steam Sterilizer, Model Top 5000 (2002), 4 descendants of its own
- 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

## Recalls of this device
- Oct 22, 2019 · Class II · Z-0604-2020: Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
- Mar 6, 2008 · Not classified · Z-2350-2008: The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is desi

## Indications for use
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities. The Eagle 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 The Eagle Century Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values: Prevacuum Configuration CYCLES | RECOMMENDED LOADS | STERILIZE 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 non-porous multiple instruments, maximum weight 17lbs | 270°F (132°C) | 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 17lbs. Up to six fabric packs. | 270°F (132°C) | 4 minutes | 20 minutes' 'Five minute Dry Time can be used for processing a single fabric pack. GRAVITY CONFIGURATION CYCLES | RECOMMENDED LOADS | STERILIZE 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 non-porous multiple instruments, maximum weight 17lbs | 270°F (132°C) | 10 minutes | 1 minute GRAVITY | Up to two double wrapped instrument trays, maximum weight 17lbs | 270°F (132°C) | 15 minutes | 30 minutes GRAVITY | Fabric Packs | 250°F (121°C) | 30 minutes’ | 15 minutes A 270°F (132°C) cycle adjusted to 25 minute Sterilize Time can be used for processing fabric packs.

Source page: https://510kreport.com/device/K964332
Methodology: https://510kreport.com/methodology