FDA product code DTL: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
DTL is the FDA product code for adaptor, stopcock, manifold, fitting, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4290 and reviewed by the Cardiovascular panel. FDA has cleared 137 510(k) submissions under DTL, from 83 different applicants. The average 510(k) review took 94 days (median 78). FDA has posted 59 recalls for DTL devices, 11 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4290 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DTL clearance
Top DTL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical Systems, Inc. | 9 | 2014-12-22 |
| North American Instrument Corp. | 5 | 1996-03-04 |
| Dlp, Inc. | 5 | 1990-08-15 |
| Texas Medical Products, Inc. | 5 | 1981-01-16 |
| Zerusa Limited | 4 | 2010-05-21 |
78 more applicants have DTL clearances. See the full list in Caduvo.
Most recent DTL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K152528 | Galt Medical Corp. | Attachable Cath Lab Hemostasis Valve | 2015-12-02 | 90 |
| K143429 | Merit Medical Systems, Inc. | Passage Hemostasis Valve | 2014-12-22 | 21 |
| K140475 | Merit Medical Systems, Inc. | ROTATING ADAPTERS | 2014-04-16 | 49 |
| K131124 | Jilin Coronado Medical , Ltd. | COLIGN | 2013-08-28 | 128 |
| K123448 | Medtronic, Inc. | AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE | 2012-12-13 | 35 |
Recalls for DTL devices
59 product recalls in 24 recall events; 11 initiated in the last five years and 11 still open. Most recent: 2026-03-24.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 6 |
| 2019 | 1 |
| 2020 | 20 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code DTL?
DTL is the FDA product code for adaptor, stopcock, manifold, fitting, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4290 and reviewed by the Cardiovascular panel.
What device class is DTL?
Class II, regulation 21 CFR 870.4290. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DTL?
Across 137 cleared submissions the average was 94 days from receipt to decision (median 78).
Which companies have the most DTL clearances?
Merit Medical Systems, Inc. (9); North American Instrument Corp. (5); Dlp, Inc. (5); Texas Medical Products, Inc. (5); Zerusa Limited (4).
Have DTL devices been recalled?
Yes: 59 product recalls across 24 recall events; the most recent began 2026-03-24.
Next steps
- Run an FDA pathway report with predicate devices for product code DTL
- Run a recall and safety report across every DTL manufacturer
- Watch product code DTL 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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