Intertech Resources, Inc.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Intertech Resources, Inc.” (first 1987, latest 1996), across 16 product codes in 3 review panels. Median 510(k) review time under this name: 90 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 | 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 4 | 4 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 3 | 3 |
| BYH | Drain, Tee (Water Trap) | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 2 | 2 |
| CAF | Nebulizer (Direct Patient Interface) | 2 | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| NHK | Resuscitator, Manual, Non Self-Inflating | 2 | 2 |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
Plus 6 more product codes.
Review panels
- Anesthesiology (25)
- General Hospital (3)
- Radiology (1)
Most recent Intertech Resources, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961318 | 1ST RESPONSE DISPOSABLE MANOMETER | CAP | 1996-12-17 | 256 |
| K955008 | HEAT & MOISTURE EXCHANGER | BYD | 1996-01-30 | 90 |
| K953580 | HEAT MOISTURE EXCHANGER | BYD | 1995-09-15 | 45 |
| K952223 | XENON GAS BREATHING CIRCUIT | IYT | 1995-08-11 | 91 |
| K952214 | SIMS INTERTECH HYPERINFLATION BAG SYSTEM | NHK | 1995-06-08 | 28 |
| K952169 | SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRIC | BTM | 1995-06-08 | 31 |
| K952062 | PFT FILTER | CAH | 1995-06-08 | 37 |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | BYD | 1994-01-25 | 118 |
| K930816 | HEPA FILTERED HME | CAH | 1993-07-01 | 134 |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | BZO | 1992-10-30 | 157 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intertech Resources, Inc..
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 Intertech Resources, Inc. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Intertech Resources, Inc.?
FDA lists 29 510(k) clearances under the applicant name “Intertech Resources, Inc.” (first 1987, latest 1996), across 16 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 Intertech Resources, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intertech Resources, Inc. is 90 days.
Which FDA product codes appear under Intertech Resources, Inc.?
The most frequent FDA product codes under this applicant name are BTM (Ventilator, Emergency, Manual (Resuscitator), 4); BYD (Condenser, Heat And Moisture (Artificial Nose), 4); CAH (Filter, Bacterial, Breathing-Circuit, 3).
Next steps
- See all 29 Intertech Resources, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTM, Intertech Resources, 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.