510(k) · Cleared
ClearedSMDIA-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Southmedic, Inc. · CAF Nebulizer (Direct Patient Interface)
Cleared on Jan 7, 2011 as substantially equivalent to K991355 (Instrumentation Industries, Inc., 2000) and 1 other predicate after a 179-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 7, 2011
- Review
- 179 days
- Class
- Class II
- Product code
- CAF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K991355 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK991355 Metered Dose Inhaler Adapter-Disposable, Adapter ReusableInstrumentation Industries, Inc. · 2000
- 1 generation backK091111 RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC…Instrumentation Industries, Inc. · 2009
- This deviceK101953 SMDIA-1000Southmedic, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K101953 | SMDIA-1000 | Southmedic, Inc. | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K991355 | Metered Dose Inhaler Adapter-Disposable, Adapter ReusableSummary page 1…CFR 868.5630 Device: Southmnedic SMDIA 1000 Predicate Devices: Instrumentation Industries K991355 - RTC-22-D K0911 11 - RTC-24V Device Description: The Southmedic SMDIA-1000 is an adaptor which… | 2000 |
| * | K091111 | RTC Metered Dose Inhaler Adapters-Single Patient Use, Model RTC 24-V, RTC Mdi Adapter…Summary page 1…Southmnedic SMDIA 1000 Predicate Devices: Instrumentation Industries K991355 - RTC-22-D K0911 11 - RTC-24V Device Description: The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of pre… | 2009 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K991355.
How does its category compare?
All CAF devicesCAF Nebulizer (Direct Patient Interface): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes.
The SMDIA-1000 MDI adaptor is single patient use, disposable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101953: SMDIA-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101953
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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