510(k) · Cleared
ClearedCodonics Safe Labeling System (SLS), Model 500I/500P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codonics, Inc. · BSZ Gas-Machine, Anesthesia
Cleared on Feb 7, 2011 as substantially equivalent to K041241 (Alaris Medical Systems, Inc., 2004) and 3 other predicates after a 259-day review. Its family tree reaches back 6 generations to 1990. 3 of the 12 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Feb 7, 2011
- Review
- 259 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K904518 (1990). 10 ancestors in all, the oldest K854213 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 5 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 4 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 3 generations backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- 2 generations backK050883 Safersleep SystemSafer Sleep, LLC · 2005
- 1 generation backK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- This deviceK101439 Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK251352 Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i…Codonics.Incorporated · 2025
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…Codonics.Incorporated · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −5 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −4 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −3 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| −2 | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| −1 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| 0 (this device) | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500P | Codonics, Inc. | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K041241 | Medley System with Bar Code Module, Model 8600Summary page 1…/Com paritive Devices: 807.92(a)(3) Codonics has identified Medley System with Bar Code Module (Pre- market notification K041 241) and the SAFERsleep System.(Pre-market notification K050883) and DocuSvs Digital Drug Management (Pre-… | 2004 |
| * | K050883 | Safersleep SystemSummary page 1…ied Medley System with Bar Code Module (Pre- market notification K041 241) and the SAFERsleep System.(Pre-market notification K050883) and DocuSvs Digital Drug Management (Pre- market notification K062388) and Philips CampuRecord Perioperati… | 2005 |
| * | K062388 | Anesthesia Information and Digital-Drug Management SystemSummary page 1…41) and the SAFERsleep System.(Pre-market notification K050883) and DocuSvs Digital Drug Management (Pre- market notification K062388) and Philips CampuRecord Perioperative System (Pre-market notification K030939)… | 2007 |
| * | K030939 | Philips Compurecord Peri-Operative Information System SoftwareSummary page 1…ital Drug Management (Pre- market notification K062388) and Philips CampuRecord Perioperative System (Pre-market notification K030939) L 3 Device Description 807.92(a)(4) 3.1 Function Drug preparation an… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i… | 2025 | 0 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 10 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K251352 (Codonics.Incorporated, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K041241.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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) and SLS Software provides a simple computer-based bar code scanning & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes, and to print labels for prepared drugs and other items in use on patients during surgical procedures. Codonics Safe Label System (SLS) is generally placed in, however not limited to, the peri-operative environment to identify syringes prepared for…
Read the full statement (121 words)
The Codonics Safe Label System (SLS) and SLS Software provides a simple computer-based bar code scanning & printing system to automatically verify drug identity from NDC and other drug vial UDI Barcodes, and to print labels for prepared drugs and other items in use on patients during surgical procedures.
Codonics Safe Label System (SLS) 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/K101439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101439: Codonics Safe Labeling System (SLS), Model 500I/500P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101439
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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