Inspiron Corp.: FDA clearances and approvals
Inspiron Corp. has 20 FDA 510(k) clearances (first 1976, latest 1986), across 15 product codes in 2 review panels. Median 510(k) review time: 14 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 | 3 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| BXJ | Clip, Nose | 1 | 1 |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
Plus 5 more product codes.
Review panels
- Anesthesiology (17)
- General Hospital (3)
Most recent Inspiron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860838 | INSPIRON DOUBLE SWIVEL TRACH ADAPTER | BZA | 1986-04-09 | 35 |
| K850346 | OXYGEN CONCENTRATOR | CAW | 1985-02-04 | 7 |
| K843932 | VAPOR-PHASE HUMIDIFIER SYS-ADVANCED | BTT | 1984-10-18 | 13 |
| K840935 | MANUAL RESUSCITATION SYSTEM | BTM | 1984-04-05 | 31 |
| K841158 | NEBULO 28 NEBULIZER KIT | BTT | 1984-03-30 | 11 |
| K840418 | INSPIRATORY/EXPIRATORY MUSCLE EXERCIS | BWF | 1984-02-17 | 17 |
| K834290 | INSPIRON LIQUID OXYGEN SYSTEM | BYJ | 1984-02-04 | 58 |
| K772072 | MANIFOLD & NEBU. FOR DOUB. LINE MACH. | CAF | 1977-11-15 | 14 |
| K772071 | MANIFOLD & NEBU. FOR SINGLE LINE MACH. | CAF | 1977-11-15 | 14 |
| K772070 | VENTILATOR SETUP, VOLUME | CAF | 1977-11-15 | 14 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Inspiron Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Inspiron Corp.'s product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Inspiron Corp. have?
Inspiron Corp. has 20 FDA 510(k) clearances (first 1976, latest 1986), across 15 product codes in 2 review panels.
How long does FDA take to clear Inspiron Corp.'s 510(k)s?
The median time from FDA receipt to decision across Inspiron Corp.'s cleared 510(k)s is 14 days.
What devices does Inspiron Corp. make?
Its most frequent FDA product codes are CAF (Nebulizer (Direct Patient Interface), 4); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 3); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Has Inspiron Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Inspiron Corp. Related entities may recall under other names.
Next steps
- See all 20 Inspiron Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Inspiron Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.