510(k) K251352

Device: Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
Applicant: Codonics.Incorporated
510(k) number: K251352
Product code: BSZ
Decision: Substantially Equivalent (SESE)
Decision date: 2025-07-11
Date received: 2025-04-30
Regulation: 868.5160
Classification name: Gas-Machine, Anesthesia
Medical specialty: Anesthesiology
Review panel: Anesthesiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

Contact: Gary Enos
Address: 17991 Englewood Dr. Middleburg Heights OH US 44130 44130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00814905021455	Codonics Safe Label System®(SLS) 700i Point of Care Station - 170C	CODONICS INC.	2026-04-20
00814905021431	Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C	CODONICS INC.	2026-04-20
00814905021417	Codonics Safe Label System®(SLS) 620i Point of Care Station - 170C	CODONICS INC.	2026-04-20
00814905021400	Codonics Safe Label System®(SLS) 610i Point of Care Station - 170C	CODONICS INC.	2026-04-20

Other 510(k) Records For Product Code BSZ#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252746	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	Drägerwerk AG Co. Kgaa	2026-05-21
K230931	Atlan	Drägerwerk AG Co. Kgaa	2023-07-23
K213867	Carestation 750/750c	Datex-Ohmeda, Inc.	2023-03-28
K201957	A8, A9 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2021-03-26
K191027	Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System	Maquet Critical Care AB	2020-03-18
K171311	A5 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2018-01-12
K171292	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2018-01-12
K172045	Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2	Datex-Ohmeda, Inc.	2017-11-03
K170872	Aisys CS2	Datex-Ohmeda, Inc.	2017-08-15
K160665	FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40	Maquet Critical Care AB	2017-03-29
K151570	Carestation 620/650/650C	Datex-Ohmeda, Inc.	2016-01-21
K151954	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2015-10-27
K143530	Aespire View	Datex-Ohmeda, Inc.	2015-04-24
K142552	A7 Anesthesia System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2015-01-23
K140264	MADM	Thornhill Research, Inc.	2015-01-05