FDA product code KIP: Formulations, Balanced Salt Solutions
KIP is the FDA product code for formulations, balanced salt solutions. It is a Class I device, regulated under 21 CFR 864.2875 and reviewed by the Pathology panel. FDA has cleared 17 510(k) submissions under KIP, from 6 different applicants. The average 510(k) review took 38 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Formulations, Balanced Salt Solutions |
| Device class | Class I |
| Regulation | 21 CFR 864.2875 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIP clearance
Top KIP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dutchland Laboratories, Inc. | 6 | 1982-04-21 |
| Sigma Chemical Co. | 4 | 1987-03-30 |
| E K Ind., Inc. | 3 | 1984-08-03 |
| Hazleton Research Products, Inc. | 2 | 1985-02-25 |
| Tissue Culture Innovations | 1 | 1986-03-12 |
1 more applicants have KIP clearances. See the full list in Caduvo.
Most recent KIP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870482 | Sigma Chemical Co. | (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 | 1987-03-30 | 55 |
| K870491 | Sigma Chemical Co. | KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 | 1987-03-30 | 55 |
| K870484 | Sigma Chemical Co. | HANKS' BALANCED SALTS (HBSS) NO. H1387 | 1987-03-30 | 55 |
| K870486 | Sigma Chemical Co. | EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 | 1987-03-30 | 55 |
| K860784 | Tissue Culture Innovations | DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 | 1986-03-12 | 9 |
Recalls for KIP devices
openFDA lists no recalls for product code KIP.
Frequently asked questions
What is FDA product code KIP?
KIP is the FDA product code for formulations, balanced salt solutions. It is a Class I device, regulated under 21 CFR 864.2875 and reviewed by the Pathology panel.
What device class is KIP?
Class I, regulation 21 CFR 864.2875. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIP?
Across 17 cleared submissions the average was 38 days from receipt to decision (median 46).
Which companies have the most KIP clearances?
Dutchland Laboratories, Inc. (6); Sigma Chemical Co. (4); E K Ind., Inc. (3); Hazleton Research Products, Inc. (2); Tissue Culture Innovations (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIP
- Run a recall and safety report across every KIP manufacturer
- Watch product code KIP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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