Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retro
Summary
Codonics.Incorporated received 510(k) clearance for 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), a BSZ device. Cleared on 2025-07-11.
Details
Source
510(k) Clearance
External ID
K251352
Action Date
2025-07-11
Status
Traditional
Category
device
Product Code
BSZ
Product Description
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). Product code: BSZ.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Codonics.Incorporated have FDA actions?
This is the only FDA action we have on record for Codonics.Incorporated in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K251352" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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