510(k) · Cleared
ClearedSaans (F4-01-00-000-000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innaccel Technologies Private Limited · SGR Noninvasive Positive Airway Pressure System, Facility Use
Cleared on Jan 6, 2026 as substantially equivalent to K222644 (Nihon Kohden Orangemed, Inc., 2023) after a 266-day review. Its family tree reaches back 4 generations to 2010. 1 of the 5 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 6, 2026
- Review
- 266 days
- Class
- Class II
- Product code
- SGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K093633 (2010). No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK093633 Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Recalled (Class I)
- 3 generations backK181695 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2018 · Recalled
- 2 generations backK192307 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020 · Recalled
- 1 generation backK222644 Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. · 2023
- This deviceK251165 Saans (F4-01-00-000-000)Innaccel Technologies Private Limited · 2026
Class I recalls in this family
- K093633 Infinity Acute Care System Workstation Critical…4 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K093633 | Infinity Acute Care System Workstation Critical Care | Draegerwerk AG & CO Kgaa | 2010 | Class I |
| −3 | K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018 | 1 |
| −2 | K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020 | 1 |
| −1 | K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023 | — |
| 0 (this device) | K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | 2026 | — |
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 SGR device
- #1 K250651 OptiPAP Junior Flexi Tube US (OPTIPAPFUS)…score 10.7 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K222644 | Nihon Kohden NKV-440 Ventilator SystemSummary page 5…3 Predicate Devices and Reference Devices 3.1 Predicate Device Predicate Device Trade Name: Nihon Kohden NKV-440 Ventilator System 510(K) Number: K222644 3.2 Reference Device 1 Reference Device Trade Name: Fisher and Paykel Healthcare Bubble CPAP System 510(K) Number:… | 2023 |
| † | K100011 | Fisher & Paykel Healthcare Bubble Cpap System | 2010 |
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.
- K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · 4 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All SGR devicesSGR Noninvasive Positive Airway Pressure System, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGR
Too few SGR 510(k)s in any year since 2007 to give a median.
Recalls per year · SGR
No recall names SGR since 2007.
Adverse event reports per year · SGR
No MAUDE report names SGR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Saans System is intended to provide continuous positive airway pressure (CPAP) support to spontaneously breathing neonates and infants weighing up to 10 kg who require respiratory assistance, including those with conditions associated with prematurity such as Respiratory Distress Syndrome (RDS). The device is intended for use in hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251165 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251165: Saans (F4-01-00-000-000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251165
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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