510(k) · Cleared
ClearedeRapid with eTrack System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pari Respiratory Equipment, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Dec 19, 2025 as substantially equivalent to K223840 (Pari Respiratory Equipment, Inc., 2023) after a 211-day review. Its family tree reaches back 8 generations to 1994. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 19, 2025
- Review
- 211 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K933535 (1994). 19 ancestors in all, the oldest K923024 (1992). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK933535 Ventstream Drug NebulizerMedic-Aid, Ltd. · 1994
- 7 generations backK981772 Halolite Aad SystemMedic-Aid, Ltd. · 1998
- 6 generations backK991685 Halolite Aad System with Dedicated CompressorMedic-Aid, Ltd. · 1999
- 5 generations backK030747 Prodose Aad SystemProfile Therapeutics Plc · 2004
- 4 generations backK042991 I-Neb Aad SystemProfile Therapeutics Plc · 2005
- 3 generations backK100380 Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc. · 2010
- 2 generations backK112859 Erapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2012
- 1 generation backK223840 eRapid Nebulizer SystemPari Respiratory Equipment, Inc. · 2023
- This deviceK251572 eRapid with eTrack SystemPari Respiratory Equipment, Inc. · 2025
Class I recalls in this family
- K990801 Minimed 508 Insulin Pump6 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933535 | Ventstream Drug Nebulizer | Medic-Aid, Ltd. | 1994 | — |
| −7 | K981772 | Halolite Aad System | Medic-Aid, Ltd. | 1998 | — |
| −6 | K991685 | Halolite Aad System with Dedicated Compressor | Medic-Aid, Ltd. | 1999 | — |
| −5 | K030747 | Prodose Aad System | Profile Therapeutics Plc | 2004 | — |
| −4 | K042991 | I-Neb Aad System | Profile Therapeutics Plc | 2005 | — |
| −3 | K100380 | Altera Nebulizer System, Model 678G1002 | Pari Respiratory Equipment, Inc. | 2010 | — |
| −2 | K112859 | Erapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2012 | — |
| −1 | K223840 | eRapid Nebulizer System | Pari Respiratory Equipment, Inc. | 2023 | — |
| 0 (this device) | K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 1 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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.
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 CAF device
- #1 K260270 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)score 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K223840 | eRapid Nebulizer SystemSummary page 5…[email protected] 2. Device Name Name of Device: eRapid with eTrack Nebulizer Common Name: Nebulizer 510(k) Number: K223840 Classification Name: Nebulizer Direct Patient Interface (21 CFR 868.5630) Regulatory Class: II Pr… | 2023 |
| † | K201167 | AireHealth NebulizerTM | 2020 |
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.
- K990801Minimed 508 Insulin PumpMedtronic Minimed · 1999 · 6 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · CAF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CAF
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAF
1in 2018
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · CAF
191in 2025
MAUDE reports naming product code CAF, 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 | 18 | 98 | 1 | 26 |
| 2008 | 12 | 123 | 0 | 11 |
| 2009 | 8 | 163 | 0 | 15 |
| 2010 | 10 | 114 | 0 | 37 |
| 2011 | 10 | 157 | 1 | 237 |
| 2012 | 9 | 126 | 0 | 138 |
| 2013 | 9 | 238 | 0 | 217 |
| 2014 | 9 | 151 | 5 | 123 |
| 2015 | 8 | 186 | 3 | 166 |
| 2016 | 5 | 186 | 1 | 201 |
| 2017 | 8 | 253 | 14 (13) | 256 |
| 2018 | 9 | 161 | 1 | 162 |
| 2019 | 3 | 266 | 0 | 185 |
| 2020 | 6 | 219 | 0 | 117 |
| 2021 | 8 | 324 | 0 | 161 |
| 2022 | 4 | 176 | 0 | 55 |
| 2023 | 8 | 279 | 0 | 107 |
| 2024 | 4 | 251 | 0 | 102 |
| 2025 | 7 | 211 | 0 | 191 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The eRapid Nebulizer System is to be used with patients for whom doctors have prescribed medicine for nebulization. It is intended for adult and pediatric patients age 4 and older who can coordinate breathing through a mouthpiece, and may be used in hospitals, hospital-type facilities, nursing homes, sub-acute institutions and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251572 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251572: eRapid with eTrack System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251572
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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