Kleen Test Products: FDA clearances and approvals
Kleen Test Products has 17 FDA 510(k) clearances (first 1976, latest 1989), across 9 product codes in 3 review panels. Median 510(k) review time: 23 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 |
|---|---|---|---|
| BXX | Calibrator, Pressure, Gas | 3 | 3 |
| MMK | Container, Sharps | 2 | 2 |
| FSM | Tray, Surgical, Instrument | 1 | 1 |
| FTA | Light, Surgical, Accessories | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| LDQ | 1 | 1 | |
| LRO | General Surgery Tray | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Kleen Test Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890039 | KLEEN TEST BASIN SET | JOL | 1989-10-24 | 287 |
| K890539 | SURE COUNT LIGHT HANDLE COVER | FTA | 1989-02-27 | 24 |
| K890098 | KLEEN TEST O.R. KIT | LRO | 1989-01-24 | 14 |
| K853622 | SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030 | — | 1985-10-10 | 42 |
| K853454 | SURE COUNT 5 & 10 SPONGE COUNTER | — | 1985-09-05 | 20 |
| K853315 | CAUTERY TIP CLEANING PAD | — | 1985-08-21 | 14 |
| K852258 | SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER | — | 1985-06-27 | 34 |
| K852257 | SURE-COUNT 15 COUNT NEEDLE COUNTER | — | 1985-06-26 | 33 |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | KKX | 1984-11-07 | 8 |
| K821396 | OUT-RITE WASTE DISPOSABLE BAG | LDQ | 1982-06-09 | 29 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kleen Test Products.
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.
Frequently asked questions
How many FDA 510(k) clearances does Kleen Test Products have?
Kleen Test Products has 17 FDA 510(k) clearances (first 1976, latest 1989), across 9 product codes in 3 review panels.
How long does FDA take to clear Kleen Test Products's 510(k)s?
The median time from FDA receipt to decision across Kleen Test Products's cleared 510(k)s is 23 days.
What devices does Kleen Test Products make?
Its most frequent FDA product codes are BXX (Calibrator, Pressure, Gas, 3); MMK (Container, Sharps, 2); FSM (Tray, Surgical, Instrument, 1).
Has Kleen Test Products had device recalls?
openFDA lists no recalls under a recalling firm name matching Kleen Test Products. Related entities may recall under other names.
Next steps
- See all 17 Kleen Test Products clearances with predicates and recalls
- Run predicate analysis for product code BXX, Kleen Test Products'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.