510(k) · Cleared
ClearedResuscitation Unit 105
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atom Medical Corporation · BZR Mixer, Breathing Gases, Anesthesia Inhalation
Cleared on Apr 20, 2011 as substantially equivalent to K060461 (Atom Medical, Inc., 2006) and 3 other predicates after a 161-day review. Its family tree reaches back 3 generations to 1976. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 20, 2011
- Review
- 161 days
- Class
- Class II
- Product code
- BZR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K760102 (1976). 12 ancestors in all. No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK760102 Flowmeter, P.C., Redesigned VersionOhio Medical Products · 1976
- 2 generations backK971243 Ohmeda Infant Resuscitation SystemOhmeda Medical · 1997
- 1 generation backK070210 Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Recalled (Class I)
- This deviceK103317 Resuscitation Unit 105Atom Medical Corporation · 2011
Class I recalls in this family
- K070210 Giraffe and Panda T- Piece Resuscitation Systemdirect predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K760102 | Flowmeter, P.C., Redesigned Version | Ohio Medical Products | 1976 | — |
| −2 | K971243 | Ohmeda Infant Resuscitation System | Ohmeda Medical | 1997 | — |
| −1 | K070210 | Giraffe and Panda T- Piece Resuscitation System | Ohmeda Medical | 2007 | Class I |
| 0 (this device) | K103317 | Resuscitation Unit 105 | Atom Medical Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 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.
1 device in this family has 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 BZR device
- #1 K243917 F&P Optiflow Air/Oxygen Flow Sourcescore 12.1 · 9 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 |
|---|---|---|---|
| * | K060461 | V-505 Infa WarmerSummary page 1…---- Preeii Medical-PreiorB i der-KE05-22- . . Atom Medical - V-5O5 Infant Warmer - K060461I GE Giraffe and Panda system - K0702 10 Device Description:… | 2006 |
| * | K925982 | BMD Air/Oxygen BlenderSummary page 1…it 105EV Resuscitation Unit 105PV _________Predicateflevices: IBio 2Medflevices - BMD air/oxvgen-blender - K925982 ---- Preeii Medical-PreiorB i der-KE05-22- . .… | 1993 |
| * | K053232 | Precision BlenderSummary page 2…* Bio-Med Devices - BMD air/oxygen blender (K925982) a blender which is incorporated into the proposed devices " Precision Medical - Precision Blender (K053232) which has the indications for use and product classification we are seeking. Table 3 compares the Resuscitation Unit 10… | 2006 |
| * | K070210 | Giraffe and Panda T- Piece Resuscitation SystemSummary page 1…. Atom Medical - V-5O5 Infant Warmer - K060461I GE Giraffe and Panda system - K0702 10 Device Description: There are two (2) models of the Resuscitation Un it 105 air / oxygen blender with… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K070210Giraffe and Panda T- Piece Resuscitation SystemOhmeda Medical · 2007 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 9.4 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K060461.
How does its category compare?
All BZR devicesBZR Mixer, Breathing Gases, Anesthesia Inhalation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BZR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZR
203in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZR
No recall names BZR since 2007.
Adverse event reports per year · BZR
13in 2025
MAUDE reports naming product code BZR, 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 | 0 | — | 0 | 15 |
| 2008 | 1 | — | 0 | 20 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 22 |
| 2011 | 2 | — | 0 | 11 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 11 |
| 2015 | 1 | — | 0 | 39 |
| 2016 | 1 | — | 0 | 30 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 24 |
| 2019 | 0 | — | 0 | 26 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 33 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 4 | 203 | 0 | 19 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103317 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103317: Resuscitation Unit 105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103317
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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