510(k) · Cleared
ClearedSalter Labs Pep Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salter Labs · CAF Nebulizer (Direct Patient Interface)
Cleared on Aug 6, 1999 as substantially equivalent to K972042 (Pari Holding Co., 1997) and 2 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 6, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954492 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- This deviceK991788 Salter Labs Pep DeviceSalter Labs · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| 0 (this device) | K991788 | Salter Labs Pep Device | Salter Labs | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 CAF? 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? (3)
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 |
|---|---|---|---|
| * | K972042 | Pari Pep Therapy SystemSummary page 3…radually decreasing orifice size corresponding to the increase in setting number. b. Predicate Devices: Product: Manufacturer: 510(k) Number: Pari #783 PEP Device Pari K972042 Breather PEP Device Instrumentation Industries, Inc. K980725 Expiratory Resistance Exerciser | Mercury Medical K954492 Table 3.1… | 1997 |
| * | K980725 | Exhalation Valve (BE 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-a)Summary page 3…e in setting number. b. Predicate Devices: Product: Manufacturer: 510(k) Number: Pari #783 PEP Device Pari K972042 Breather PEP Device Instrumentation Industries, Inc. K980725 Expiratory Resistance Exerciser | Mercury Medical K954492 Table 3.1 Predicate Devices Salter Labs 510(k) Submission for PEP Dev… | 1998 |
| * | K954492 | Mercury Medical Expiratory Resistance Exerciser, ResistexSummary page 3…facturer: 510(k) Number: Pari #783 PEP Device Pari K972042 Breather PEP Device Instrumentation Industries, Inc. K980725 Expiratory Resistance Exerciser | Mercury Medical K954492 Table 3.1 Predicate Devices Salter Labs 510(k) Submission for PEP Device 39 ¢. Comparative Product Matrix The… | 1996 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K972042.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
This product is indicated for use in patients where enhanced medicated aerosol deposition or lung exercise is recommended by a physician or licensed clinician. This device is intended to be used in the hospital, clinic and home care markets, The Salter Labs PEP device is designed to be used with the Salter Labs Nebutech Nebulizer-series Mouthpiece as a stand-alone device, or the device may be used in conjunction with the Salter Labs Nebutech Nebulizer…
Read the full statement (127 words)
This product is indicated for use in patients where enhanced medicated aerosol deposition or lung exercise is recommended by a physician or licensed clinician. This device is intended to be used in the hospital, clinic and home care markets,
The Salter Labs PEP device is designed to be used with the Salter Labs Nebutech Nebulizer-series Mouthpiece as a stand-alone device, or the device may be used in conjunction with the Salter Labs Nebutech Nebulizer and the Salter Labs Aerosol Filter during the nebulization process.
This product is a nebulizer accessory that connects to the exhalation port of the Salter Labs Nebutech Nebulizer mouthpiece and serves to provide a controllable exhalation resistance of from 5 to 20 cm H20 at flow rates ranging from 10 to 55 L/min,
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/K991788 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991788: Salter Labs Pep Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991788
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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