Codonics Safe Labeling System (SLS), Model 500I/500P
FDA 510(k) K101439 · Codonics, Inc.
510(k) numberK101439
Submission
- Device name
- Codonics Safe Labeling System (SLS), Model 500I/500P
- Applicant
- Codonics, Inc.
Middleburg Heights, OH, US - Received
- May 24, 2010
- Decision date
- February 7, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSZ – Gas-Machine, Anesthesia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5160
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/25/2026SE |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ · Traditional | Drägerwerk AG Co. Kgaa | 05/21/2026SE |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…BSZ · Traditional | Codonics.Incorporated | 07/11/2025SE |
| K230931 | AtlanBSZ · Traditional | Drägerwerk AG Co. Kgaa | 07/23/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | Datex-Ohmeda, Inc. | 03/28/2023SE |
| K201957 | A8, A9 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 03/26/2021SE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional | Maquet Critical Care AB | 03/18/2020SE |
| K171311 | A5 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K171292 | A7 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | Datex-Ohmeda, Inc. | 11/03/2017SE |
More from Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…BSZ · Traditional | 07/11/2025SE |
| K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon Xl-X Long Film…LMC · Special | 03/16/2006SE |
| K042232 | NP-2600 Series Hardcopy PrintersLMC · Traditional | 10/05/2004SE |
| K030690 | Codonics EP-1000 Medical Color Dry ImagersLMC · Traditional | 04/30/2003SE |
| K021054 | Codonics Horizon Ci Medical Multimedia Dry Imager; Codonics Horizon GS Medical…LMC · Traditional | 05/09/2002SE |
| K003481 | Codonics NP-1660 Series Medical Printers, Model 1660LMC · Traditional | 01/19/2001SE |
| K962364 | Codonics Medical Printer (NP-1600M,NP1600MD)LMC · Traditional | 11/08/1996SE |
Questions and answers
When was Codonics Safe Labeling System (SLS), Model 500I/500P cleared by the FDA?
Codonics Safe Labeling System (SLS), Model 500I/500P (K101439) received a 510(k) decision of Substantially Equivalent on February 7, 2011, 259 days after the submission was received.
What is the product code of K101439?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.