510(k) · Cleared
ClearedCodonics 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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codonics.Incorporated · BSZ Gas-Machine, Anesthesia
Cleared on Jul 11, 2025 as substantially equivalent to K101439 (Codonics, Inc., 2011) after a 72-day review. Its family tree reaches back 7 generations to 1990. 3 of the 12 devices in its family, counting itself, have a Class I recall.
- Decided
- Jul 11, 2025
- Review
- 72 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K904518 (1990). 11 ancestors in all, the oldest K854213 (1985). No later device cites it as a predicate yet. 3 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 6 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 5 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 4 generations backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- 3 generations backK050883 Safersleep SystemSafer Sleep, LLC · 2005
- 2 generations backK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- 1 generation backK101439 Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011
- This deviceK251352 Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i…Codonics.Incorporated · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −6 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −5 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −4 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| −3 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| −2 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| −1 | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500P | Codonics, Inc. | 2011 | — |
| 0 (this device) | K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and… | Codonics.Incorporated | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 1 | 0 |
| 2003 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BSZ device
- #1 K253330 A5 Anesthesia System (A5); A7 Anesthesia…score 16.7 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500PSummary page 5…The Codonics Safe Label System 700i and related 610i, 620i, 630i, SLS-XXX RFID series is a continuation of the SLS device cleared to market per K101439. SLS 700i and related series when equipped with RFID is a new version release. The… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K041241Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BSZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSZ
145in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSZ
5in 2025
Class I (38 since 2007) Class II/III not classified
Adverse event reports per year · BSZ
9,198in 2025
MAUDE reports naming product code BSZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 175 | 1 | 132 |
| 2008 | 8 | 99 | 8 | 104 |
| 2009 | 3 | 34 | 3 | 85 |
| 2010 | 1 | — | 14 | 97 |
| 2011 | 6 | 218 | 1 | 87 |
| 2012 | 5 | 134 | 7 (6) | 89 |
| 2013 | 5 | 125 | 5 (5) | 308 |
| 2014 | 4 | 235 | 0 | 279 |
| 2015 | 4 | 134 | 7 (2) | 572 |
| 2016 | 1 | — | 1 | 2,135 |
| 2017 | 3 | 145 | 5 (1) | 2,355 |
| 2018 | 2 | — | 3 | 2,589 |
| 2019 | 0 | — | 5 (2) | 1,957 |
| 2020 | 1 | — | 7 | 2,687 |
| 2021 | 1 | — | 2 (1) | 3,123 |
| 2022 | 0 | — | 4 (3) | 4,352 |
| 2023 | 2 | — | 6 | 5,595 |
| 2024 | 0 | — | 13 (13) | 6,067 |
| 2025 | 1 | — | 5 (3) | 9,198 |
| 2026 | 2 | — | 7 (2) | — |
What is it indicated for?
The Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features and safe and effective released SLS Software provides a simple computer-based bar code scanning/RFID & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes and (when configured and available) RFID parenteral vial information and formulary information, and to print labels embedded with RFID tags for…
Read the full statement (188 words)
The Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features and safe and effective released SLS Software provides a simple computer-based bar code scanning/RFID & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes and (when configured and available) RFID parenteral vial information and formulary information, and to print labels embedded with RFID tags for prepared drugs and other items in use on patients during surgical procedures. Drug information is human readable on labels, 2D & Linear barcoded on labels, and RFID encoded as part of secondary container medication labels.
Codonics Safe Label System SLS 700i and related 610i, 620i, 630i series enabled to receive RFID features is generally placed in, however not limited to, the peri-operative environment to identify syringes prepared for anesthesiology use during surgery. Additional uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS can also be used to print “non-surgical environment” color & text labels as required. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251352: 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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251352
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026