Model note · Autoclave
STERIS AMSCO 400 Series steam sterilizer
The AMSCO 400 is a STERIS steam sterilizer for heat and moisture stable items, built in small (16 and 20 inch) and medium (26 inch) chamber sizes for operating theatres and sterile services departments. It is validated for immediate use processing and offers prevacuum, gravity, liquid, leak test and Bowie-Dick (DART) cycles, with an optional steam flush pressure pulse (SFPP) cycle. A vertical sliding door worked by a foot pedal and a non-lubricated, steam activated door seal are its most recognisable design traits.
The model
Maker, model and type.
- Maker
- STERIS Corporation
- Model
- AMSCO 400 Series steam sterilizer
- Device type
- Autoclave
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Chamber sizes (small) | 16 x 16 x 26 in (406 x 406 x 660 mm, 108.79 L) and 20 x 20 x 38 in (508 x 508 x 965 mm, 249.03 L) | Source |
| Chamber size (medium) | 26 x 26 x 39 in (models 39SL and 39CSL) | Source |
| Outside dimensions (20 x 20 small) | About 45 5/8 in long x 30 in wide x 74 1/2 in high (1159 x 762 x 1891 mm), varies slightly by configuration | Source |
| Factory cycles | Prevacuum, Gravity, Liquid, Leak Test and DART (Bowie-Dick); SFPP models (16S, 16CS, 20S, 20CS) add Steam Flush Pressure-Pulse | Source |
| Typical prevacuum cycle | 132 C (270 F) for 4 minutes, dry time 20 minutes for fabric packs or 30 minutes for double wrapped trays | Source |
| Liquid cycle | 121 C (250 F) for 45 minutes, validated with three 1000 ml bottles; for non-patient-contact use only | Source |
| Maximum tray weight | 25 lb (11.3 kg) per instrument tray | Source |
| Recommended full load (20 x 20 x 38) | 3 wrapped instrument trays or 6 fabric packs | Source |
| Regulatory class | FDA Class II steam sterilizer, 21 CFR 880.6880, product code FLE | Source |
| Door seal warranty | 2 year warranty on the steam activated gasket | Source |
Recalls
Known FDA recalls.
- Z-0915-20132013-02-12
Control board alarm set points and temperature tolerances could trigger an analog/digital alarm as temperature fluctuated, locking up the sterilizer.
FDA record - Z-1561-20152015-02-19
Control board software in some units interrupted and cancelled a cycle when the scheduled shutdown time fell during processing.
FDA record - Z-0210-20162015-09-03
On units with the CS-iQ feature, software could prevent the foot pedal from opening and closing the door.
FDA record
Safety
Safety warnings from the record.
- The liquid cycle is validated only for non-patient-contact use. Do not use it to process items that will touch a patient. Source
- Keep each instrument tray at or below 25 lb (11.3 kg) and follow the recommended load quantities for the chamber size, as cycles were validated at those loads. Source
- The sterilizer is designed only for heat and moisture stable materials. Heat or moisture sensitive items need a different process. Source
- STERIS training covers when the emergency exhaust valve should be used. Learn that procedure from STERIS documents before working on a pressurised unit. Source
Sources
Where this note comes from.
- STERIS AMSCO 400 Series Small Steam Sterilizer product page
- FDA 510(k) K212424 summary, AMSCO 400 Small and Medium Steam Sterilizers
- STERIS service training outline, AMSCO 400 Steam Sterilizer
- Soma Technology spec sheet, AMSCO 400 Series (reseller, secondary source)
- openFDA MAUDE product problem counts, brand AMSCO 400
- openFDA recalls, product description AMSCO 400
Not covered: No public STERIS operator or maintenance manual was found, so alarm codes, utility requirements (tech data sheet SD937) and the service troubleshooting tree are not included; the RTD and vacuum details come from a reseller sheet and should be checked against STERIS documents.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Autoclave