Ati Disp. Biological Test Pack for Ethylene Oxide

Q: What is the product code of K895704?

The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.

FDA 510(k) K895704 · Pymah Corp., Ati Div.

Substantially Equivalent

510(k) numberK895704

Submission

Device name: Ati Disp. Biological Test Pack for Ethylene Oxide
Applicant: Pymah Corp., Ati Div.
Potomac, MD, US
Received: September 22, 1989
Decision date: March 8, 1990
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: FRC – Indicator, Biological Sterilization Process
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.2800
Specialty: General Hospital

Other 510(k)s with product code FRC

510(k)	Device	Applicant	Decision
K260766	Celerity 5 HP Biological Indicator (LCB052)FRC · Special	STERIS Corporation	04/08/2026SE
K252680	Celerity 20 HP Biological IndicatorFRC · Special	STERIS Corporation	09/24/2025SE
K251122	Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional	Terragene	08/04/2025SE
K251452	Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special	Steris	06/06/2025SE
K250061	Celerity IncubatorFRC · Special	STERIS Corporation	02/06/2025SE
K250044	Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special	STERIS Corporation	02/06/2025SE
K243501	3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional	3M Company	01/28/2025SE
K242453	Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional	Terragene S.A.	12/12/2024SE
K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional	3M Company	11/25/2024SE
K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional	3M Company	10/18/2024SE

More from 3M Company

510(k)	Device	Decision
K884615	Ati-Pymah Disposable Steam Biological Test PackFRC · Traditional	01/19/1989SE
K884767	Ati-Pymah Disposable Biological Test PackFRC · Traditional	01/10/1989SE

Questions and answers

When was Ati Disp. Biological Test Pack for Ethylene Oxide cleared by the FDA?

Ati Disp. Biological Test Pack for Ethylene Oxide (K895704) received a 510(k) decision of Substantially Equivalent on March 8, 1990, 167 days after the submission was received.

What is the product code of K895704?

The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.