510(k) · Cleared
ClearedSafersleep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Safer Sleep, LLC · BSZ Gas-Machine, Anesthesia
Cleared on Nov 4, 2005 as substantially equivalent to K030939 (Philips Medical Systems, 2003) and 1 other predicate after a 211-day review. Its family tree reaches back 4 generations to 1990. 3 of the 15 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it.
- Decided
- Nov 4, 2005
- Review
- 211 days
- Class
- Class II
- Product code
- BSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904518 (1990). 8 ancestors in all, the oldest K854213 (1985). 6 later devices descend from it, 2 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 1 generation backK041241 Medley System with Bar Code Module, Model 8600Alaris Medical Systems, Inc. · 2004 · Recalled (Class I)
- This deviceK050883 Safersleep SystemSafer Sleep, LLC · 2005
- Descendant · cites it directly · 5 of its ownK062388 Anesthesia Information and Digital-Drug Management SystemDocusys · 2007
- Descendant · 2 generations on · 2 of its ownK141474 Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK182092 BD Intelliport SystemBecton, Dickinson and Company · 2019
- Descendant · cites it directly · 1 of its ownK101439 Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK251352 Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i…Codonics.Incorporated · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K062388Anesthesia Information and Digital-Drug Management SystemDocusys · 2007 · cites it directly5descendants
- K141474Becton Dickinson Intelliport SystemBecton, Dickinson & CO · 2014 · 2 generations on2descendants
- K182092BD Intelliport SystemBecton, Dickinson and Company · 2019 · 3 generations on1descendant
- K101439Codonics Safe Labeling System (SLS), Model 500I/500PCodonics, Inc. · 2011 · cites it directly1descendant
- K251352Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…Codonics.Incorporated · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −1 | K041241 | Medley System with Bar Code Module, Model 8600 | Alaris Medical Systems, Inc. | 2004 | Class I |
| 0 (this device) | K050883 | Safersleep System | Safer Sleep, LLC | 2005 | — |
| +1 | K062388 | Anesthesia Information and Digital-Drug Management System | Docusys | 2007 | — |
| +2 | K141474 | Becton Dickinson Intelliport System | Becton, Dickinson & CO | 2014 | 1 |
| +3 | K182092 | BD Intelliport System | Becton, Dickinson and Company | 2019 | — |
| +1 | K101439 | Codonics Safe Labeling System (SLS), Model 500I/500P | Codonics, Inc. | 2011 | — |
| +2 | 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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K030939 | Philips Compurecord Peri-Operative Information System SoftwareSummary page 1…ntial Equiv alence The SAFERsleep Systemn is substantially equivalent to the Philips Compurecord Peri-Operative Anesthesiology Information System Software (K03 093 9). Both systems arc softwvare application programs that run on Windows-based personal computers. Both systems are i… | 2003 |
| * | K041241 | Medley System with Bar Code Module, Model 8600Summary page 4…022 In addition, the bar code capability of the SAFERsleep System has a predicate basis in the Medley System with Bar Code Module (K041241), manufactured by Alaris Medical Systems. In both systems, the bar code feature is intended for use as a means to i… | 2004 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 8 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K062388 (Docusys, 2007) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K030939.
How does its category compare?
All BSZ devicesBSZ Gas-Machine, Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SAFERsteep System is a software-based product intended for use by an anesthetist to assist in the safe administration and record keeping of drugs used during an anesthetic procedure.
The SAFERsleep System provides an integrated method of information collection and documentation on drugs administered and concurrent anesthetic monitor data. The system also includes ease of use features to reduce the possibility of errors in drug administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050883 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050883: Safersleep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050883
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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