# K070461: Verify Steam Indicators, Models 250F 25, 250F 30, 270F 15, 270F 3-10 and 270F 4

- Pathway: 510(k) (Abbreviated)
- Applicant: STERIS Corporation
- Decided: Jul 17, 2007 after 151 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960441 (1997). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960441: Steritec Integraph Model CI-101, Steritec Products Mfg Co, Inc. (1997) Summary page 2.
- (no number) 3M SteriGage Chemical Indicators: named in the summary without a submission number
- (no number) DANA SteriScan Indicators: named in the summary without a submission number
- (no number) STERIS Verify Integrators: named in the summary without a submission number

## Most influential descendants
- K182724: CelerityTM 10 STEAM Chemical Indicator (2018), 0 descendants of its own
- K162758: VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack (2017), 0 descendants of its own
- K102894: Classix Chemical Sterilization Indicator (2011), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class III · Z-1793-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
The Verify® Steam Indicators are emulating indicators intended for use in steam sterilization. The Verify® Steam Indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The indicator models and their cycle temperatures, types, and times are: Verify 250F 30 250°F (121°C) gravity steam 30 minutes Verify 270F 15 270°F (132 0 C) gravity steam 15 minutes Verify 270F 3-10 270 0 F (132 0 C) gravity flash steam 3 or 10 minutes Verify 270F 4 270°F (132°C) Steam Flush Pressure Pulse 4 minutes (SFPP), pre-vacuum and Express steam

Source page: https://510kreport.com/device/K070461
Methodology: https://510kreport.com/methodology