Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NVP — Predicate Candidate Screening
16 FDA 510(k) clearances under this product code; the 50 most recent screened below.
266 daysmedian FDA review time
474 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242667 | AeroChamber2go Anti-Static Valved Holding Chamber | Trudell Medical International | 2025-01-15 | 132 | 0 |
| K210558 | LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber | Thayer Medical Corporation | 2022-04-01 | 400 | 0 |
| K181649 | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chambe | Trudell Medical International | 2019-01-11 | 203 | 0 |
| K160109 | Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding | Thayer Medical Corporation | 2017-05-19 | 486 | 0 |
| K143615 | Antistatic Compact Space Chamber | Medical Developments International Limited | 2016-01-26 | 403 | 0 |
| K140062 | FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER | Fsc Laboratories, Inc. | 2014-10-03 | 266 | 1 |
| K122252 | SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS | Medical Developments International | 2013-11-13 | 474 | 0 |
| K130598 | INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER | Inspirx, Inc. | 2013-06-05 | 90 | 0 |
| K112010 | AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2012-07-11 | 363 | 0 |
| K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | Respironics New Jersey, Inc. | 2011-08-09 | 189 | 0 |
| K101348 | AGACHAMBER SPACER | Aga Plastic Ind. Com. Ltda. | 2011-04-29 | 351 | 0 |
| K110136 | RESPICHAMBER VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2011-04-18 | 90 | 0 |
| K101136 | FISIO CHAMBER SPACE | Koo (Shanghai) Industries Co., Ltd. | 2011-01-28 | 281 | 0 |
| K080100 | WATCHHALER | Activaero America, Inc. | 2008-06-30 | 168 | 0 |
| K070674 | AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLO | Trudell Medical Intl. | 2007-04-11 | 30 | 0 |
| K052332 | AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER | Trudell Medical Intl. | 2005-09-21 | 26 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda