Sechrist Industries, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Sechrist Industries, Inc.” (first 1978, latest 2014), across 10 product codes in 3 review panels. Median 510(k) review time under this name: 71 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 86 |
| 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 8 | 8 |
| CBF | Chamber, Hyperbaric | 5 | 5 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 2 | 2 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| DTX | Gas Control Unit, Cardiopulmonary Bypass | 1 | 1 |
| FPK | Tubing, Fluid Delivery | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (20)
- Cardiovascular (1)
- General Hospital (1)
Most recent Sechrist Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | 2014-05-30 | 86 |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | 2010-04-26 | 87 |
| K052713 | MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER | CBF | 2005-10-28 | 29 |
| K023745 | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G | DTX | 2003-01-17 | 71 |
| K993167 | MILLENNIUM INFANT VENTILATOR | CBK | 1999-11-10 | 49 |
| K992503 | SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES | BZR | 1999-08-10 | 14 |
| K950386 | MODEL 3200P/3200PR HYPERBARIC CHAMBER | CBF | 1995-06-13 | 132 |
| K934164 | MODEL 2500E/2500ER HYPERBARIC CHAMBER | CBF | 1995-06-13 | 655 |
| K930713 | THE INFANT FLOW SYSTEM | CAI | 1993-09-16 | 217 |
| K914607 | SEHRIST VOLUME VENTILATOR, MODEL 2200B | CBK | 1992-11-02 | 382 |
13 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2015-06-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Sechrist Industries, Inc. (a text match, not an official crosswalk):
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sechrist (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sechrist Industries, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Sechrist Industries, Inc.” (first 1978, latest 2014), across 10 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sechrist Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sechrist Industries, Inc. is 71 days.
Which FDA product codes appear under Sechrist Industries, Inc.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 8); CBF (Chamber, Hyperbaric, 5); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 2).
Next steps
- See all 23 Sechrist Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Sechrist Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.