# K220564: 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: May 23, 2022 after 84 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K932129 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101528: 3M Comply Lead Free Process Indicators for Steam, 3M Company (2010) Summary page 5.

## Most influential descendants
- K251991: SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (2025), 0 descendants of its own

## Indications for use
3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed for use by a health care provider to accompany individual units (e.g. wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 in steam process below: Cycle Type Temperature Exposure Time Gravity 250 °F/121°C 30 minutes Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes Gravity 275 °F/135°C 3, 10 minutes Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes Dynamic air-removal 275 °F/135°C 3, 3.5, 4, 10 minutes Use the 3M™ Comply™ Lead Free Steam Indicator Tape 1322 to demonstrate that packs have been exposed to the sterilization process. The 3M™ Comply™ Lead Free Steam Indicator Tape 1322 is designed to secure packs wrapped with untreated woven and disposable non-woven paper and paper/plastic wraps. 3M™ Attest™ Lead Free Steam Indicator Tape 1355 for disposable wraps is designed for use by a health care provider to accompany individual units (e.g., wrapped packs) to demonstrate that the unit has been exposed to the sterilization process and to distinguish between processed and unprocessed units. Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 in steam process below: Cycle Type Temperature Exposure Time Gravity 250 °F/121°C 30 minutes Gravity 270 °F/132°C 3, 4, 10, 15, 25 minutes Gravity 275 °F/135°C 3, 10 minutes Dynamic air-removal 250 °F/121°C 15, 20, 30 minutes Dynamic air-removal 270 °F/132°C 3, 3.5, 4, 5.5, 6, 9, 10, 15 minutes Dynamic air-removal 273 °F/134°C 3, 3.5, 4 minutes Dynamic air-removal 275 °F/135°C 3, 3.5, 4, 10 minutes Use the 3M™ Attest™ Lead Free Steam Indicator Tape 1355 to demonstrate that packs have been exposed to the sterilization process. The 3M™ Attest™ Lead Free Steam Indicator Tape 1355 is designed to secure packs wrapped with disposable non-woven, paper and paper/plastic wraps.

Source page: https://510kreport.com/device/K220564
Methodology: https://510kreport.com/methodology