King Systems Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “King Systems Corp.” (first 1988, latest 2004), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | 5 | 5 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 3 | 3 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| BSF | Absorber, Carbon-Dioxide | 1 | 1 |
| BSJ | Mask, Gas, Anesthetic | 1 | 1 |
| BTC | Bag, Reservoir | 1 | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| CBH | Device, Fixation, Tracheal Tube | 1 | 1 |
| CBP | Valve, Non-Rebreathing | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (12)
- General Hospital (5)
- Radiology (1)
Most recent King Systems Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 | CAE | 2004-05-04 | 216 |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | CAE | 2004-04-14 | 196 |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | CAE | 2003-01-09 | 237 |
| K012485 | MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE | CAH | 2001-10-09 | 68 |
| K010040 | SLEEVED FILTER | CAH | 2001-03-09 | 63 |
| K990614 | HME-BOOSTER | BTT | 2000-05-23 | 453 |
| K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | CAH | 1999-03-01 | 123 |
| K973797 | BREATHING CIRCUIT BACTERIAL FILTER | CAH | 1998-03-12 | 157 |
| K953513 | XENON CIRCUIT | IYT | 1995-11-03 | 100 |
| K951093 | KAB SYSTEM | BSF | 1995-03-24 | 15 |
8 earlier clearances. See the full list in Caduvo.
Recalls
195 product recalls in 11 recall events; 0 initiated in the last five years. Most recent: 2015-02-17.
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.
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.
- King Diagnostics, Inc. (41 510(k)s)
- King & Spalding (7 510(k)s)
- King Dental Corp. (2 510(k)s)
- King Handy Five Corp. (2 510(k)s)
- King'S Sunglass Corp. (2 510(k)s)
- King I Tech Corporation (1 510(k)s)
- King Kondom Products, Inc. (1 510(k)s)
- King Mfg. Co. (1 510(k)s)
- King'S Bay Intl., Inc. (1 510(k)s)
- King Tool, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under King Systems Corp.?
FDA lists 18 510(k) clearances under the applicant name “King Systems Corp.” (first 1988, latest 2004), across 11 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 King Systems Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name King Systems Corp. is 76 days.
Which FDA product codes appear under King Systems Corp.?
The most frequent FDA product codes under this applicant name are CAH (Filter, Bacterial, Breathing-Circuit, 5); CAE (Airway, Oropharyngeal, Anesthesiology, 3); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 2).
Next steps
- See all 18 King Systems Corp. clearances with predicates and recalls
- Run predicate analysis for product code CAH, King Systems Corp.'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.