510(k) · Cleared
ClearedAdult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexicare Medical Limited. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Dec 7, 2018 as substantially equivalent to K042682 (Ambu, Inc., 2004) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Dec 7, 2018
- Review
- 175 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K042843 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK042843 Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsAmbu, Inc. · 2004 · Recalled
- This deviceK181583 Adult Single Use Resuscitator Bag without Pressure Relief, Adult…Flexicare Medical Limited. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042843 | Ambu Spur II Infant and Pediatric Single Patient Use Resuscitators | Ambu, Inc. | 2004 | 1 |
| 0 (this device) | K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use… | Flexicare Medical Limited. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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.
Planning a device in BTM? 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 2 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 |
|---|---|---|---|
| * | K042682 | Ambu Spur II. Adult Single Patient ResuscitatorSummary page 4…keted Equivalent Device: Flexicare’s Adult Single Use Resuscitator Bag is substantially equivalent to Ambu’s SPUR II Adult Single Patient Use Resuscitator cleared under K042682. Flexicare’s Pediatric Single Use Resuscitator Bag is substantially equivalent to Ambu’s SPUR II Pediatric Single Patient Use Re… | 2004 |
| * | K042843 | Ambu Spur II Infant and Pediatric Single Patient Use ResuscitatorsSummary page 4…d under K042682. Flexicare’s Pediatric Single Use Resuscitator Bag is substantially equivalent to Ambu’s SPUR II Pediatric Single Patient Use Resuscitator cleared under K042843. Flexicare’s Infant Single Use Resuscitator Bag is substantially equivalent to Ambu’s SPUR II Infant Single Patient Use Resuscit… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 3 other devices also cite its predicate K042682.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
Flexicare’s Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments. Flexicare’s Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency…
Read the full statement (149 words)
Flexicare’s Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments.
Flexicare’s Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments.
Flexicare’s Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181583: Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181583
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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