Intersurgical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Intersurgical, Inc.” (first 1991, latest 2023), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 198 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 | 2 | 184 |
| 2013 | 1 | 178 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 237 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intersurgical, Inc. took a median 237 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 249 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 10 | 10 |
| BZA | Connector, Airway (Extension) | 4 | 4 |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 1 | 1 |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
Review panels
- General Hospital (10)
- Anesthesiology (9)
Most recent Intersurgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020) | CAH | 2023-06-15 | 237 |
| K122077 | MANOMETER | CAP | 2013-01-10 | 178 |
| K122075 | DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER | CCK | 2012-12-20 | 157 |
| K121026 | FLO-GUARD BREATHING FILTER | CAH | 2012-11-02 | 212 |
| K092451 | INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER | CAH | 2010-10-29 | 445 |
| K092129 | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 | BZE | 2010-05-18 | 307 |
| K092409 | HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER | CAH | 2010-03-10 | 216 |
| K032322 | CLEAR-THERM MICRO HME, MODEL 1441 | CAH | 2004-05-13 | 290 |
| K024270 | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 | CAH | 2003-06-24 | 183 |
| K990949 | CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT | CAH | 1999-06-15 | 85 |
9 earlier clearances. See the full list in Caduvo.
Recalls
14 product recalls in 9 recall events; 6 initiated in the last five years. Most recent: 2026-06-15.
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 Intersurgical, 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.
- Intersurgical Incorporated (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intersurgical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Intersurgical, Inc.” (first 1991, latest 2023), across 7 product codes in 2 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 Intersurgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intersurgical, Inc. is 198 days.
Which FDA product codes appear under Intersurgical, Inc.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 10); BZA (Connector, Airway (Extension), 4); BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer, 1).
Next steps
- See all 19 Intersurgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAH, Intersurgical, 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.