510(k) · Cleared
ClearedMetered Dose Inhaler Adapter-Disposable, Adapter Reusable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Industries, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 27, 2000 after a 283-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jan 27, 2000
- Review
- 283 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK991355 Metered Dose Inhaler Adapter-Disposable, Adapter ReusableInstrumentation Industries, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK091111 RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC…Instrumentation Industries, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK162753 RTC 26-C Inline Aerosol AdapterInstrumentation Industries, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK101953 SMDIA-1000Southmedic, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK101857 RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VInstrumentation Industries, Inc. · 2010
Most influential descendants
Showing 4 of 4 · See all- K091111RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…Instrumentation Industries, Inc. · 2009 · cites it directly2descendants
- K162753RTC 26-C Inline Aerosol AdapterInstrumentation Industries, Inc. · 2017 · cites it directly0descendants
- K101953SMDIA-1000Southmedic, Inc. · 2011 · cites it directly0descendants
- K101857RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-VInstrumentation Industries, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter Reusable | Instrumentation Industries, Inc. | 2000 | — |
| +1 | K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi… | Instrumentation Industries, Inc. | 2009 | — |
| +1 | K162753 | RTC 26-C Inline Aerosol Adapter | Instrumentation Industries, Inc. | 2017 | — |
| +1 | K101953 | SMDIA-1000 | Southmedic, Inc. | 2011 | — |
| +2 | K101857 | RTC-24 VP Metered Dose Inhaler Adapter, Model RTC 24-V | Instrumentation Industries, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K091111 (Instrumentation Industries, Inc., 2009) has gone furthest, with 2 descendants of its own.
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?
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.
The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991355: Metered Dose Inhaler Adapter-Disposable, Adapter Reusable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991355
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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